Drug Abuse, Narcotic Abuse, Opiate Addiction, Opioid-Related Disorders
Conditions
Brief summary
The purpose of this study is to evaluate the effect on pain intensity (PI) of structured discontinuation of long-term opioid analgesic therapy compared to continuation of opioid therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy for chronic low back pain (CLBP).
Detailed description
This was a multicenter, randomized, double-blind, placebo-controlled study which consisted of a common Screening Visit for all subjects, then different schedules for Optimal and Suboptimal Responders, followed by a common schedule for the Blinded Structured Opioid Discontinuation Period (BSODP) and Follow-up Period. The original protocol (10 Jan 2016) was amended twice: Amendment 1 (07 Jul 2016) and Amendment 2 (08 Feb 2017). Screening of subjects only started after Amendment 1 approval. Approximately half the subjects were screened under Amendment 1 and half under Amendment 2. The original statistical analysis plan (SAP) was amended twice as well based on the protocol amendments. The current SAP is version 1.3, dated 11 April 2018, which added a section to list the analyses that were not being completed as a result of the premature termination of this study. The duration of the entire study for each subject was approximately 33 to 37 weeks. For Suboptimal Responders: the study duration included Screening Period of up to 3 weeks, Run-in Period of 1 week, Baseline Period of 1 week, Blinded Structured Opioid Discontinuation Period of 24 weeks, and Follow-up Period of 4 weeks. For Optimal Responders: the study duration included Screening Period of up to 3 weeks, Observation Period of 1 week, Taper Period up to 2 weeks, Open Label Titration Period of 3 weeks, Blinded Structured Opioid Discontinuation Period of 24 weeks, and Follow-up Period of 4 weeks. The primary endpoint was the change in the mean Average PI score on the 0-10 Numerical Ratings Scale (NRS) from Baseline to the 1 week period before the Week 12 visit. Data were summarized using descriptive statistics (number of observations \[n\], mean, standard deviation, median, first and third quartiles, minimum, and maximum for continuous variables; and frequency and percentage for categorical variables). Due to the inability to recruit a sufficient number of subjects over an acceptable period of time, the study was terminated prematurely and efficacy analyses were reduced and only a brief summary of the statistical analyses of the primary endpoint in each group (Suboptimal Responders and Optimal Responders) were performed.
Interventions
DRUGStructured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
DRUGContinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
Sponsors
Member Companies of the Opioid PMR Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be male or non-pregnant, non-lactating female aged 18 to 75 years, inclusive. 2. Have a clinical diagnosis of non-radicular CLBP (pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks) of Class 1 or proximal radicular (above the knee) pain of Class 2 based on the Quebec Task Force Classification for Spinal Disorders (subjects with previous surgery or chronic pain syndrome, i.e., classes 9.2 or 10, will be allowed if their pain does not radiate or radiates only proximally) for a minimum of 12 months and 1. For the Suboptimal Responder group, pain must have been present for at least several hours a day and have an Average PI score of 6-9 on an 11-point NRS within the past 24 hours of screening. 2. For the Optimal Responder group, subjects must have an Average PI score of 1-4 on an 11-point NRS within the past 24 hours of screening. 3. Have been taking ER/LA opioids or immediate release opioids (at least 4 times at day) for at least 12 months. 4. Have been taking one of the 3 index ER opioid drugs around-the-clock at a twice-a-day frequency for at least 3 consecutive months at a total daily dose within the range shown below. Daily Dose Range 1. Morphine sulfate extended-release: 120-540mg 2. Oxycodone extended-release: 80-360mg 3. Oxymorphone extended-release: 40-180mg 5. Be considered, in the opinion of the Investigator, to be in generally good health other than CLBP at screening based upon the results of a medical history, physical examination, 12-lead ECG, and laboratory profile. 6. Speak, read, write, and understand English (to reduce heterogeneity of data), understand the consent form, and be able to effectively communicate with the study staff. 7. Have access to the Internet (to access the patient support program). 8. Voluntarily provide written informed consent. 9. Be willing and able to complete study procedures.
Exclusion criteria
1. Have any clinically significant condition that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or increase the risk of opioid-related AEs. 2. Have a primary diagnosis of fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness, bowel or bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis, diskitis, back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm. 3. Have undergone a surgical procedure for back pain within 6 months prior to the Screening Visit. 4. Have had a nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the Screening Visit or botulinum toxin injection in the lower back region within 3 months prior to screening. 5. Have a history of confirmed malignancy within past 2 years, with exception of basal cell or squamous cell carcinoma of the skin that has been successfully treated. 6. Have uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure \>180 mm Hg or \<90 mm Hg, or a sitting diastolic blood pressure \>110 mmHg or \<40 mm Hg at screening. 7. Have a body mass index (BMI) \>45 kg/m2. Anyone with a BMI \>40 but \<45 will complete a screening tool (STOPBang Questionnaire) to rule out high risk of obstructive sleep apnea. 8. Have clinically significant depression based on a score of ≥20 on the Patient Health Questionnaire (PHQ-8) 9. Have suicidal ideation associated with actual intent and a method or plan in the past year: Yes answers on items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS). 10. Have a previous history of suicidal behaviors in the past 5 years: Yes answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS. 11. Have any lifetime history of serious or recurrent suicidal behavior. (Non-suicidal self-injurious behavior is not a trigger for a risk assessment unless in the Investigator's judgment it is indicated.) 12. Have clinically significant abnormality in clinical chemistry, hematology or urinalysis, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase ≥3 times the upper limit of the reference range or a serum creatinine \>2 mg/dL at screening. 13. Have severe enough psychiatric or substance abuse disorder to compromise the subject's safety or scientific integrity of the study. 14. Have on-going litigation associated with back pain or pending applications for workers compensation or disability issues or subjects who plan on filing litigation or claims within the next 12 months; subjects with settled past litigations will be allowed as will subjects who have been on workers compensation or disability claims for at least 3 months. 15. Have used a monoamine oxidase inhibitor within 14 days prior to the start of study medication. 16. Are taking agonist-antagonists (pentazocine, butorphanol or nalbuphine), buprenorphine, methadone, barbiturates, or more than one type of benzodiazepine within 1 month prior to screening. 17. Have a positive urine drug test (UDT) for illicit drugs (including marijuana), non-prescribed controlled substances (opioid or non-opioid), or alcohol at screening. 18. Have taken any investigational drug within 30 days prior to the Screening Visit or are currently enrolled in another investigational drug study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to the 1 week period prior to the Week 12 visit | Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Suboptimal Responders. |
| Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Optimal Responders. |
| Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Weeks 12 and 24 | The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index. The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep). |
| Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | 4 weeks prior to baseline and prior to 12 and 24 week visits | Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents \< 7 hours or \> 8 hours. |
| Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | Weeks 12 and 24 | The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression. |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to weeks 4, 8, 16, 20, and 24 | Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. |
| Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Baseline and weeks 12, 24 | The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level. |
| Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Baseline to 12 and 24 week visit | The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state. |
| Digit Symbol Substitution Test | Change from Baseline to 12 and 24 week visit | Overall neuropsychological function is assessed using the DSST, a test that is sensitive to brain damage, dementia, age, and depression, and is a widely used instrument for measuring the neuropsychological effects of opioid therapy. The digits (1-9) are paired with symbols, and the test consists of matching the symbol for a series of digits as fast as possible. Score is number of correct symbols in 90 seconds. A decrease from baseline detects deterioration in processing speed. An increase from baseline detects improvement in processing speed. |
| Patient Global Impression of Change (PGIC) | Baseline to 12 and 24 week visit | The Patient Global Impression of Change (PGIC) is a self-administered questionnaire that assesses the participant's level of improvement/worsening from the beginning to the end of treatment. Participants are asked to select the category of change that most closely describes any change experienced in the pain of their painful areas from the beginning of the Blinded Structured Opioid Discontinuation Period to Week 12 and to Week 24. The scale has levels describing change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. |
| Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Change from Baseline to 12 and 24 week visit | For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline. |
| Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Baseline, 12 and 24 week visit | The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score \>= 10 is considered major depression and \>= 20 is severe major depression. |
Countries
United States
Participant flow
Recruitment details
First Subject First Visit 14 September 2016; Date of Early Study Termination 29 January 2018
Pre-assignment details
Prior to randomization, subjects gave consent and entered a pre-assignment period that assessed eligibility for the intervention phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder | 13 |
| Continuation of Opioid Therapy Suboptimal Responder Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder | 12 |
| Structured Discontinuation Opioid Therapy Optimal Responder Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder | 3 |
| Continuation of Opioid Therapy Optimal Responder Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder | 4 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 |
| Overall Study | No additional information available | 0 | 0 | 1 | 1 |
| Overall Study | Sponsor Request | 2 | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Structured Discontinuation Opioid Therapy Suboptimal Responder | Continuation of Opioid Therapy Suboptimal Responder | Structured Discontinuation Opioid Therapy Optimal Responder | Continuation of Opioid Therapy Optimal Responder | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 9 Participants | 3 Participants | 4 Participants | 28 Participants |
| Age, Continuous | 56.5 years | 56.1 years | 41.7 years | 49.8 years | 54.1 years |
| Age, Customized <25 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 25-49 | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 10 Participants |
| Age, Customized 50-64 | 9 Participants | 5 Participants | 1 Participants | 3 Participants | 18 Participants |
| Age, Customized Equal to or greater than 65 | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 1 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 2 Participants | 2 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 0 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 3 Participants | 3 Participants | 24 Participants |
| Region of Enrollment United States | 13 participants | 12 participants | 3 participants | 4 participants | 32 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 1 Participants | 2 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 2 Participants | 2 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 9 / 13 | 7 / 12 | 2 / 3 | 1 / 4 |
| serious Total, serious adverse events | 1 / 13 | 0 / 12 | 0 / 3 | 0 / 4 |
Outcome results
Primary
Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.
Time frame: From baseline to the 1 week period prior to the Week 12 visit
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | -0.2198 Score on a scale | Standard Deviation 0.83544 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | -0.3328 Score on a scale | Standard Deviation 1.00514 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 0.3750 Score on a scale | Standard Deviation 1.28794 |
| Continuation of Opioid Therapy Optimal Responder | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 1.00 Score on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression.
Time frame: Weeks 12 and 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 12 Weeks | -1.2 Score on a scale | Standard Deviation 4.75 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 24 Weeks | 0.7 Score on a scale | Standard Deviation 3.47 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 24 Weeks | -1.1 Score on a scale | Standard Deviation 3.98 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 12 Weeks | -0.8 Score on a scale | Standard Deviation 4.94 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 12 Weeks | 3.3 Score on a scale | Standard Deviation 6.81 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 24 Weeks | 0.00 Score on a scale | Standard Deviation 7.07 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 12 Weeks | 3.3 Score on a scale | Standard Deviation 6.5 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | 24 Weeks | -1.3 Score on a scale | Standard Deviation 0.58 |
Secondary
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index. The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep).
Time frame: Weeks 12 and 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 24 | 0.0 Score on a scale | Standard Deviation 35.28 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 12 | 3.1 Score on a scale | Standard Deviation 21.36 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 12 | -5.4274 Score on a scale | Standard Deviation 13.32784 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 24 | 4.8333 Score on a scale | Standard Deviation 22.9152 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 12 | -5.673 Score on a scale | Standard Deviation 18.5378 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 12 | 0.00 Score on a scale | Standard Deviation 37.42 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 12 | 10.00 Score on a scale | Standard Deviation 18.26 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 12 | -4.6154 Score on a scale | Standard Deviation 20.43683 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 12 | -4.1026 Score on a scale | Standard Deviation 12.25907 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 12 | 0.1 Score on a scale | Standard Deviation 0.95 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 24 | 5.375 Score on a scale | Standard Deviation 18.4283 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 24 | 0.0 Score on a scale | Standard Deviation 42.16 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 24 | 10.0 Score on a scale | Standard Deviation 34.32 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 24 | 6.0000 Score on a scale | Standard Deviation 33.47378 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 24 | 6.6667 Score on a scale | Standard Deviation 25.09242 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 24 | -0.8 Score on a scale | Standard Deviation 1.81 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 12 | 0.00 Score on a scale | Standard Deviation 26.97 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 12 | -0.1 Score on a scale | Standard Deviation 1.31 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 12 | 2.7778 Score on a scale | Standard Deviation 25.33945 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 12 | 10.00 Score on a scale | Standard Deviation 27.63 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 24 | -6.8056 Score on a scale | Standard Deviation 17.251 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 24 | -10.313 Score on a scale | Standard Deviation 12.4418 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 12 | -5.00 Score on a scale | Standard Deviation 35.3754 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 24 | 13.8 Score on a scale | Standard Deviation 19.23 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 24 | 0.0 Score on a scale | Standard Deviation 38.54 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 24 | -9.1667 Score on a scale | Standard Deviation 20.91176 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 24 | 10.0 Score on a scale | Standard Deviation 41.4 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 24 | -4.1667 Score on a scale | Standard Deviation 24.92847 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 12 | -0.2778 Score on a scale | Standard Deviation 16.66414 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 12 | -2.222 Score on a scale | Standard Deviation 15.63651 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 24 | -0.1 Score on a scale | Standard Deviation 1.46 |
| Continuation of Opioid Therapy Suboptimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 12 | 0.8 Score on a scale | Standard Deviation 24.29 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 12 | 13.3 Score on a scale | Standard Deviation 23.09 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 12 | 0.00 Score on a scale | Standard Deviation 40 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 24 | 0.5 Score on a scale | Standard Deviation 0.71 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 12 | 6.6667 Score on a scale | Standard Deviation 17.63834 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 12 | 4.4444 Score on a scale | Standard Deviation 12.6198 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 12 | 2.0370 Score on a scale | Standard Deviation 15.23816 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 24 | -6.6667 Score on a scale | Standard Deviation 18.85618 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 12 | -2.3 Score on a scale | Standard Deviation 2.89 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 24 | -5.00 Score on a scale | Standard Deviation 14.1421 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 24 | -2.2222 Score on a scale | Standard Deviation 21.99888 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 24 | 40.00 Score on a scale | Standard Deviation 28.28 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 24 | 20.0 Score on a scale | Standard Deviation 28.28 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 24 | 25.0 Score on a scale | Standard Deviation 21.21 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 12 | 3.3 Score on a scale | Standard Deviation 25.17 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 12 | -0.417 Score on a scale | Standard Deviation 8.3229 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 24 | 16.6667 Score on a scale | Standard Deviation 32.99832 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 24 | -10.000 Score on a scale | Standard Deviation 3.75 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 12 | 15.00 Score on a scale | Standard Deviation 19.15 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 24 | -11.1111 Score on a scale | Standard Deviation 7.698 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 12 | 0.5 Score on a scale | Standard Deviation 0.58 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 12 | 1.8056 Score on a scale | Standard Deviation 12.50823 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 12 | 10.00 Score on a scale | Standard Deviation 11.55 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 12 | 0.8333 Score on a scale | Standard Deviation 9.9536 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 24 | 0.00 Score on a scale | Standard Deviation 20 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Somnolence Week 12 | 8.3333 Score on a scale | Standard Deviation 14.78237 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index I Week 24 | -2.2222 Score on a scale | Standard Deviation 11.70628 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Quantity Week 24 | 0.0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Problems Index II Week 24 | -2.2222 Score on a scale | Standard Deviation 6.40698 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Snoring Week 24 | 13.3 Score on a scale | Standard Deviation 11.55 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Adequacy Week 12 | 5.00 Score on a scale | Standard Deviation 19.15 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Awaken Short of Breath or Headache Week 24 | 40.00 Score on a scale | Standard Deviation 40 |
| Continuation of Opioid Therapy Optimal Responder | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Sleep Disturbance Week 12 | 2.813 Score on a scale | Standard Deviation 16.5635 |
Secondary
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.
Time frame: From baseline to weeks 4, 8, 16, 20, and 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 4 weeks | -0.1123 Score on a scale | Standard Deviation 0.77962 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 24 weeks | -0.5000 Score on a scale | Standard Deviation 0.83692 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 20 weeks | -0.4153 Score on a scale | Standard Deviation 0.81486 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 16 weeks | -0.3462 Score on a scale | Standard Deviation 0.79086 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 8 weeks | -0.3671 Score on a scale | Standard Deviation 0.8681 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 4 weeks | -0.1413 Score on a scale | Standard Deviation 0.99386 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 8 weeks | 0.0984 Score on a scale | Standard Deviation 0.62794 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 16 weeks | -0.5714 Score on a scale | Standard Deviation 1.37382 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 20 weeks | -0.6873 Score on a scale | Standard Deviation 1.08941 |
| Continuation of Opioid Therapy Suboptimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 24 weeks | -0.1532 Score on a scale | Standard Deviation 1.23299 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 20 weeks | -0.4821 Score on a scale | Standard Deviation 1.08591 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 16 weeks | -0.6964 Score on a scale | Standard Deviation 1.38896 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 24 weeks | 0.2857 Score on a scale | — |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 4 weeks | 0.4940 Score on a scale | Standard Deviation 0.64818 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 8 weeks | 0.3393 Score on a scale | Standard Deviation 0.63135 |
| Continuation of Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 8 weeks | 0.1413 Score on a scale | Standard Deviation 0.25046 |
| Continuation of Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 24 weeks | 1.5 Score on a scale | — |
| Continuation of Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 20 weeks | -0.3095 Score on a scale | Standard Deviation 0.03367 |
| Continuation of Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 16 weeks | 0.4508 Score on a scale | Standard Deviation 0.48807 |
| Continuation of Opioid Therapy Optimal Responder | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | 4 weeks | 0.3143 Score on a scale | Standard Deviation 0.38951 |
Secondary
Digit Symbol Substitution Test
Overall neuropsychological function is assessed using the DSST, a test that is sensitive to brain damage, dementia, age, and depression, and is a widely used instrument for measuring the neuropsychological effects of opioid therapy. The digits (1-9) are paired with symbols, and the test consists of matching the symbol for a series of digits as fast as possible. Score is number of correct symbols in 90 seconds. A decrease from baseline detects deterioration in processing speed. An increase from baseline detects improvement in processing speed.
Time frame: Change from Baseline to 12 and 24 week visit
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Digit Symbol Substitution Test | Week 12 from baseline | 7.8 Score on a test | Standard Deviation 8.23 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Digit Symbol Substitution Test | Week 24 from baseline | 8.9 Score on a test | Standard Deviation 8.41 |
| Continuation of Opioid Therapy Suboptimal Responder | Digit Symbol Substitution Test | Week 24 from baseline | 0.1 Score on a test | Standard Deviation 12.84 |
| Continuation of Opioid Therapy Suboptimal Responder | Digit Symbol Substitution Test | Week 12 from baseline | 6.1 Score on a test | Standard Deviation 10.22 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Digit Symbol Substitution Test | Week 12 from baseline | 3.3 Score on a test | Standard Deviation 7.64 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Digit Symbol Substitution Test | Week 24 from baseline | -6.0 Score on a test | Standard Deviation 5.66 |
| Continuation of Opioid Therapy Optimal Responder | Digit Symbol Substitution Test | Week 12 from baseline | 0.00 Score on a test | Standard Deviation 4.83 |
| Continuation of Opioid Therapy Optimal Responder | Digit Symbol Substitution Test | Week 24 from baseline | -3.3 Score on a test | Standard Deviation 7.64 |
Secondary
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score \>= 10 is considered major depression and \>= 20 is severe major depression.
Time frame: Baseline, 12 and 24 week visit
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Baseline | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Severe Major Depression Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Major Depression Week 24 | 0 Participants |
Secondary
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Suboptimal Responders.
Time frame: Weeks 12 and 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 12 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 24 | 5 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 24 | 8 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 12 | 7 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 24 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 12 | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 10% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | >0% (any improvement) Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 0 Participants |
Secondary
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Optimal Responders.
Time frame: Weeks 12 and 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 40% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 30% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Equal to 0% (any worsening) Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 40% week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than 0% (any worsening) Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than 0% (any worsening) Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Equal to 0% (any worsening) Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 40% week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 30% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 40% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Equal to 0% (any worsening) Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than 0% (any worsening) Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 40% Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 40% week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 30% Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 40% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 30% Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 12 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 20% Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 12 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 40% week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than or equal to 10% Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | greater than or equal to 30% Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Greater than 0% (any worsening) Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Equal to 0% (any worsening) Week 12 | 2 Participants |
Secondary
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level.
Time frame: Baseline and weeks 12, 24
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 24 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing week 12 | 5 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed baseline | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed baseline | 5 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort baseline | 7 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing baseline | 10 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort baseline | 6 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities baseline | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities baseline | 10 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to washing or dressing Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 12 | 8 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 24 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Baseline | 8 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 24 | 5 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed baseline | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 12 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 12 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 24 | 5 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 12 | 7 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 12 | 11 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 24 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 12 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 12 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 12 | 4 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Baseline | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 12 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed baseline | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 12 | 7 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 12 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 12 | 6 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 24 | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to washing or dressing Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Baseline | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Baseline | 7 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Baseline | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Baseline | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Baseline | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing baseline | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing baseline | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing baseline | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Baseline | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities baseline | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities baseline | 6 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort baseline | 6 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort baseline | 6 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed baseline | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed baseline | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 12 | 6 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 12 | 9 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 12 | 7 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 12 | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 24 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 24 | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 24 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 24 | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 24 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 24 | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 24 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 24 | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 24 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to washing or dressing Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Baseline | 3 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Baseline | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Baseline | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Baseline | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 12 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 12 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 24 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 12 | 3 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight pain or discomfort baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderately anxious or depressed Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 12 | 3 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate Problem Walking Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severely anxious or depressed Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Week 24 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight Problem Walking Week 12 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed Week 24 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to washing or dressing Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem Walking Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem doing usual activities Baseline | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem doing usual activities Baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities baseline | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to wash or dress baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem doing usual activities Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate pain or discomfort baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing baseline | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem doing usual activities Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extreme pain or discomfort baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Not anxious or depressed baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | No problem washing or dressing Baseline | 3 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Extremely anxious or depressed Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slightly anxious or depressed baseline | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to Walk Baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Slight problem washing or dressing Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Moderate problem washing or dressing week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe Problem Walking Baseline | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Unable to do usual activities Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Severe problem washing or dressing Week 12 | 0 Participants |
Secondary
Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)
The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state.
Time frame: Baseline to 12 and 24 week visit
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 12 visit | 5.5 Score on a scale | Standard Deviation 11.45 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 24 visit | 4.5 Score on a scale | Standard Deviation 18.68 |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 12 visit | 3.2 Score on a scale | Standard Deviation 25.89 |
| Continuation of Opioid Therapy Suboptimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 24 visit | 8.4 Score on a scale | Standard Deviation 28.57 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 24 visit | -4.5 Score on a scale | Standard Deviation 13.44 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 12 visit | -17.7 Score on a scale | Standard Deviation 12.01 |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 12 visit | -6.3 Score on a scale | Standard Deviation 7.97 |
| Continuation of Opioid Therapy Optimal Responder | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Week 24 visit | 0.3 Score on a scale | Standard Deviation 5.86 |
Secondary
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents \< 7 hours or \> 8 hours.
Time frame: 4 weeks prior to baseline and prior to 12 and 24 week visits
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Baseline | 10 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Baseline | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 12 | 11 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 24 | 9 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 24 | 7 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 12 | 10 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Baseline | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Baseline | 9 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Baseline | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Baseline | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 12 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 12 | 3 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 24 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Baseline | 3 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=0 Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | Index=1 Baseline | 1 Participants |
Secondary
Patient Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is a self-administered questionnaire that assesses the participant's level of improvement/worsening from the beginning to the end of treatment. Participants are asked to select the category of change that most closely describes any change experienced in the pain of their painful areas from the beginning of the Blinded Structured Opioid Discontinuation Period to Week 12 and to Week 24. The scale has levels describing change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Time frame: Baseline to 12 and 24 week visit
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 12 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 24 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | No change Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 12 | 8 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | No change Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 24 | 3 Participants |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | No change Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 12 | 5 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | No change Week 12 | 3 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 12 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 12 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 12 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 24 | 1 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 24 | 4 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 24 | 2 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 24 | 0 Participants |
| Continuation of Opioid Therapy Suboptimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | No change Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 24 | 2 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | No change Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 12 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 24 | 0 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 12 | 1 Participants |
| Structured Discontinuation Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 24 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 24 | 2 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much improved Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally improved Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | No change Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very Much Worse Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 24 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Minimally Worse Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Very much improved Week 12 | 0 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | Much Worse Week 12 | 1 Participants |
| Continuation of Opioid Therapy Optimal Responder | Patient Global Impression of Change (PGIC) | No change Week 12 | 0 Participants |
Secondary
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline.
Time frame: Change from Baseline to 12 and 24 week visit
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 24 | 0.40 Score on a scale | Standard Deviation 3.007 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 24 | 1.8 Score on a scale | Standard Deviation 2.59 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 24 | -0.72 Score on a scale | Standard Deviation 1.277 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 24 | -1.0 Score on a scale | Standard Deviation 7.68 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 12 | 2.2 Score on a scale | Standard Deviation 1.3 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 12 | 0.23 Score on a scale | Standard Deviation 1.28 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 12 | 0.65 Score on a scale | Standard Deviation 3.312 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 24 | -0.6 Score on a scale | Standard Deviation 7.33 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 12 | 2.0 Score on a scale | Standard Deviation 7.14 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 12 | -0.10 Score on a scale | Standard Deviation 0.849 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 12 | -1.0 Score on a scale | Standard Deviation 5.2 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 12 | 0.38 Score on a scale | Standard Deviation 2.711 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 24 | 0.48 Score on a scale | Standard Deviation 1.301 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 24 | 3.4 Score on a scale | Standard Deviation 1.67 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 12 | 1.8 Score on a scale | Standard Deviation 1.79 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 24 | 1.80 Score on a scale | Standard Deviation 0.561 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 12 | -0.05 Score on a scale | Standard Deviation 2.216 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 24 | 1.4 Score on a scale | Standard Deviation 13.56 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 12 | 0.00 Score on a scale | Standard Deviation 2.368 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 24 | 0.88 Score on a scale | Standard Deviation 3.411 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 12 | -1.0 Score on a scale | Standard Deviation 5.2 |
| Structured Discontinuation Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 24 | 0.30 Score on a scale | Standard Deviation 2.205 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 24 | -0.90 Score on a scale | Standard Deviation 1.559 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 24 | 0.27 Score on a scale | Standard Deviation 0.462 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 24 | -0.4 Score on a scale | Standard Deviation 11.26 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 12 | -0.40 Score on a scale | Standard Deviation 3.046 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 12 | -4.6 Score on a scale | Standard Deviation 10.26 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 24 | 2.2 Score on a scale | Standard Deviation 2.05 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 12 | -0.86 Score on a scale | Standard Deviation 1.544 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 12 | 2.69 Score on a scale | Standard Deviation 2.589 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 12 | -1.4 Score on a scale | Standard Deviation 5.22 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 12 | -0.47 Score on a scale | Standard Deviation 1.614 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 24 | 0.8 Score on a scale | Standard Deviation 1.64 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 24 | 0.30 Score on a scale | Standard Deviation 0.52 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 12 | 0.91 Score on a scale | Standard Deviation 2.65 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 24 | 0.4 Score on a scale | Standard Deviation 4.83 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 24 | -0.67 Score on a scale | Standard Deviation 1.155 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 24 | 0.80 Score on a scale | Standard Deviation 1.386 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 12 | 1.0 Score on a scale | Standard Deviation 2.35 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 12 | 1.4 Score on a scale | Standard Deviation 3.36 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 24 | 0.4 Score on a scale | Standard Deviation 5.41 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 24 | -1.40 Score on a scale | Standard Deviation 1.51 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 12 | -1.0 Score on a scale | Standard Deviation 4.24 |
| Continuation of Opioid Therapy Suboptimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 12 | 0.94 Score on a scale | Standard Deviation 1.514 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 12 | 0.5 Score on a scale | Standard Deviation 0.71 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 12 | 0.0 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 12 | 0.5 Score on a scale | Standard Deviation 0.71 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 12 | 1.5 Score on a scale | Standard Deviation 2.12 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 12 | 0.00 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 12 | -4.40 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 24 | 0.0 Score on a scale | Standard Deviation 2.83 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 12 | -6.00 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 12 | -3.60 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 12 | -0.40 Score on a scale | Standard Deviation 0 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 12 | 4.0 Score on a scale | Standard Deviation 2.83 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 24 | 7.0 Score on a scale | Standard Deviation 9.9 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 24 | 1.5 Score on a scale | Standard Deviation 0.71 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 24 | -1.5 Score on a scale | Standard Deviation 3.54 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 24 | 2.0 Score on a scale | Standard Deviation 2.83 |
| Structured Discontinuation Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 12 | -3.20 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 24 | 0.90 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 24 | 0.40 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 12 | 1.5 Score on a scale | Standard Deviation 0.71 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 24 | 0.00 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Satisfaction Week 12 | 0.0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 12 | 0.0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Orgasmic Function Week 24 | 2.0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 12 | 0.20 Score on a scale | Standard Deviation 0.283 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 24 | 0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Arousal Week 12 | 1.35 Score on a scale | Standard Deviation 0.636 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 12 | 0.0 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Sexual Desire Week 24 | 0.0 Score on a scale | Standard Deviation 1.41 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 24 | 0.00 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Desire Week 12 | 0.30 Score on a scale | Standard Deviation 0.424 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Pain Week 12 | -0.40 Score on a scale | Standard Deviation 1.131 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Intercourse Satisfaction Week 24 | 1.5 Score on a scale | Standard Deviation 0.71 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 24 | 0.0 Score on a scale | Standard Deviation 1.41 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 12 | 2.00 Score on a scale | Standard Deviation 7.07 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Orgasm Week 24 | -0.40 Score on a scale | Standard Deviation 0 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Overall Satisfaction Week 12 | 0.5 Score on a scale | Standard Deviation 2.12 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Male Erectile Function Week 24 | 4.5 Score on a scale | Standard Deviation 0.71 |
| Continuation of Opioid Therapy Optimal Responder | Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women | Female Lubrication Week 12 | 0.30 Score on a scale | Standard Deviation 0 |