Opioid Withdrawal (Disorder)
Conditions
Keywords
Opioid Withdrawal Syndrome, OWS, Opioid taper, Opioid withdrawal, Opioid reduction, Stopping opioids, Opioid discontinuation, non-opioid pain management
Brief summary
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
Detailed description
This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain. Subjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.
Interventions
DRUGLofexidine
Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
DRUGPlacebo
Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Sponsors
USWM, LLC (dba US WorldMeds)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All subjects, study personnel (including the Investigator, study coordinator(s), pharmacist/designee), and the Sponsor will be blinded to the identity of the study drug (active or placebo) administered to subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject can provide written informed consent. * Chronic non-cancer pain diagnosis such as low back pain, chronic neck pain, osteoarthritis, and prolonged post-surgical pain with daily pain for a minimum of 6 months. * Self-reported use of prescribed oral opioid medication(s) (tablets, pills or capsules) of at least 50 morphine mg equivalent (MME) but no higher than 240 mg MME daily or near daily (≥5 days per week) for at least 12 weeks and seeking to discontinue their opioid medication. * Willing to be treated with non-opioid treatments for pain (in addition to opioid being tapered) for duration of study. * Willing to abstain from alcohol use during the study. * Willing to partner with his or her pain physician on a subject-centered pain management plan during the study. * In generally good health, in the opinion of the Investigator, other than the underlying chronic pain syndrome * Women of childbearing potential must have a negative pregnancy test at Screening. * Non-pregnant, non-lactating women who are postmenopausal, naturally or surgically sterile, or who agree to use acceptable contraceptive methods throughout the course of the study. * Other criteria will be discussed in detail with potential subjects by Site Investigator
Exclusion criteria
* Has a primary diagnosis of complex regional pain syndrome, central neuropathic pain, somatoform pain syndromes, acute nerve root compression, any acute or progressive infectious, inflammatory, or neurological process. * Taking methadone, buprenorphine, fentanyl rapid acting products, tapentadol, tramadol, butorphanol, meperidine, or levorphanol for any reason * Liver disease that requires medication or medical treatment, and/or AST or ALT levels greater than 3 x ULN. * Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment. * Has a diagnosis of epilepsy or history of seizures. * Cardiovascular abnormalities at Screening and before randomization (stable hypertension permitted) * Self-reported or evidence of opioid use disorder (OUD) or other substance use disorder within last 12 months * Any severe or unstable psychiatric disorder including post-traumatic stress disorder, schizophrenia, bipolar disorder, major depression, substance abuse, or suicidality as determined by the Investigator. * Subject answers yes to suicidal ideation in prior 24 months to any items 1 through 5 on the C-SSRS, or subject answers yes to any lifetime suicidal behavior item on the C-SSRS. * Any anticipated or scheduled surgery during the study period or within 30 days before Screening. * Other criteria will be discussed in detail with potential subjects by site Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent AEs and SAEs | Day 1 through Day 28 | — |
| Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation | Day 1 through Day 28 | — |
| Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests | Day 1 through Day 28 | — |
| Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale | Day 1 through Day 28 | The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains yes or no questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a yes in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds yes to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral. |
| Change in Blood Pressure | Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 | Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes. |
| Change in Pulse | Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Clinical Global Impression - Subject Version (MCGI-S) | Each scheduled evaluation (Day 1 through Day 28) | Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug. SEVERITY OF OPIATE WITHDRAWAL: 1. = No opiate withdrawal symptoms 2. = On the border between no to mild opiate withdrawal symptoms 3. = Mild opiate withdrawal symptoms 4. = Moderate opiate withdrawal symptoms 5. = Marked opiate withdrawal symptoms 6. = Severe opiate withdrawal symptoms 7. = The most severe opiate withdrawal symptoms that I have ever had SIDE EFFECTS INDEX (Scale B): 1. = None. The study drug has no side effects 2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities 3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities 4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides |
| Time to Study Drug Discontinuation | Day 1 through Day 28 | Study day of participant discontinuation. |
| Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 1 through Day 28 | — |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale | Change from Baseline to EOS | The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of 0 - I have no problems or I am not to a maximum of 5 - I am unable to or I am extremely. The dimensions are averaged together for a single score and the change in average score from baseline is recorded. |
| Change in Short Form Health Survey (SF-36) Scale | Change from baseline to End of Study, up to 55 days | The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale. The final value reported is the average change in the averaged scale scores from baseline to end of study. |
| Change in Insomnia Severity Index (ISI) | Change from baseline to Days 15 and End of Study, up to 55 days | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). |
| Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation | Day 1 through Day 28 | — |
| Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Baseline through Follow-up (assessed daily) | A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable. |
| Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 through Day 28 (assessed daily) | The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable. |
| Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Baseline through Day 51 (assessed daily) | The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable. |
| Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 through Day 28 (assessed daily) | The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable. |
| Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Baseline through Day 28 | — |
| Change in Hospital Anxiety and Depression Scale (HADS) | Change from End of Study to Baseline, up to 55 days | The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study. |
| Change in Clinical Opiate Withdrawal Scale (COWS) | Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28 | The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48. |
| Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 | The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome. |
| Change in Daily Opioid Dose as a Percentage of the Baseline MED | Baseline through Day 28 | — |
| Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28 | The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome. |
| Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS) | MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug. SEVERITY OF ILLNESS: 1. = No at all ill 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects SIDE EFFECTS INDEX: 1. = None, study drug is producing no side effects 2. = Do not significantly interfere with subject's functioning 3. = Significantly interferes with subject's functioning 4. = Outweighs therapeutic effect |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lofexidine Lofexidine: Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day. | 1 |
| Placebo Placebo: Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day. | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Lofexidine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 3 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
Change in Blood Pressure
Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.
Time frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Population: A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. Orthostatic vital signs only collected in clinic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Blood Pressure | Day 23: Diastolic BP | -3.5 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 14: Diastolic BP | -8 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 26: Diastolic BP | 1.5 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 14: Systolic BP | -42 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 2: Diastolic BP | -7 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 15: Diastolic BP | -10 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 3: Systolic BP | -52 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 26: Systolic BP | -14 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 22: Diastolic BP | -16 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 24: Diastolic BP | -1.5 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 7: Diastolic BP | -16 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 1: Systolic BP | -6 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 7: Systolic BP | -50 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 23: Systolic BP | -19 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 8: Systolic BP | -44 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 8: Diastolic BP | -10 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 1: Diastolic BP | -2 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 15: Systolic BP | -32 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 2: Systolic BP | -25 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 22: Systolic BP | -25 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 3: Diastolic BP | -16 mmHg | — |
| Lofexidine | Change in Blood Pressure | Day 24: Systolic BP | -23.5 mmHg | — |
| Placebo | Change in Blood Pressure | Day 15: Diastolic BP | -4 mmHg | — |
| Placebo | Change in Blood Pressure | Day 8: Diastolic BP | -8 mmHg | — |
| Placebo | Change in Blood Pressure | Day 22: Systolic BP | -34 mmHg | — |
| Placebo | Change in Blood Pressure | Day 8: Systolic BP | -36 mmHg | — |
| Placebo | Change in Blood Pressure | Day 15: Systolic BP | -40 mmHg | — |
| Placebo | Change in Blood Pressure | Day 22: Diastolic BP | -8 mmHg | — |
| Placebo | Change in Blood Pressure | Day 3: Systolic BP | -44 mmHg | — |
| Placebo | Change in Blood Pressure | Day 1: Diastolic BP | 0 mmHg | — |
| Placebo | Change in Blood Pressure | Day 1: Systolic BP | 0 mmHg | — |
| Placebo | Change in Blood Pressure | Day 3: Diastolic BP | -9 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 24: Systolic BP | 9.5 mmHg | Standard Deviation 6.61 |
| Placebo: Sitting | Change in Blood Pressure | Day 7: Systolic BP | 6 mmHg | Standard Deviation 7 |
| Placebo: Sitting | Change in Blood Pressure | Day 1: Diastolic BP | -0.3 mmHg | Standard Deviation 3.06 |
| Placebo: Sitting | Change in Blood Pressure | Day 1: Systolic BP | 1.7 mmHg | Standard Deviation 2.31 |
| Placebo: Sitting | Change in Blood Pressure | Day 2: Diastolic BP | 3 mmHg | Standard Deviation 5.66 |
| Placebo: Sitting | Change in Blood Pressure | Day 2: Systolic BP | 7 mmHg | Standard Deviation 9.9 |
| Placebo: Sitting | Change in Blood Pressure | Day 3: Diastolic BP | 1.5 mmHg | Standard Deviation 3.87 |
| Placebo: Sitting | Change in Blood Pressure | Day 3: Systolic BP | 6.5 mmHg | Standard Deviation 7.72 |
| Placebo: Sitting | Change in Blood Pressure | Day 7: Diastolic BP | 7 mmHg | Standard Deviation 8.72 |
| Placebo: Sitting | Change in Blood Pressure | Day 8: Diastolic BP | 3.3 mmHg | Standard Deviation 9.45 |
| Placebo: Sitting | Change in Blood Pressure | Day 8: Systolic BP | 4 mmHg | Standard Deviation 11 |
| Placebo: Sitting | Change in Blood Pressure | Day 14: Diastolic BP | 1.7 mmHg | Standard Deviation 10.5 |
| Placebo: Sitting | Change in Blood Pressure | Day 14: Systolic BP | 4.7 mmHg | Standard Deviation 10.02 |
| Placebo: Sitting | Change in Blood Pressure | Day 15: Diastolic BP | 1 mmHg | Standard Deviation 7.81 |
| Placebo: Sitting | Change in Blood Pressure | Day 15: Systolic BP | 10.7 mmHg | Standard Deviation 16.07 |
| Placebo: Sitting | Change in Blood Pressure | Day 18: Diastolic BP | 10.7 mmHg | Standard Deviation 6.35 |
| Placebo: Sitting | Change in Blood Pressure | Day 18: Systolic BP | 14.3 mmHg | Standard Deviation 0.58 |
| Placebo: Sitting | Change in Blood Pressure | Day 19: Diastolic BP | 6.3 mmHg | Standard Deviation 4.5 |
| Placebo: Sitting | Change in Blood Pressure | Day 19: Systolic BP | 11 mmHg | Standard Deviation 6.22 |
| Placebo: Sitting | Change in Blood Pressure | Day 20: Diastolic BP | 1.8 mmHg | Standard Deviation 5.91 |
| Placebo: Sitting | Change in Blood Pressure | Day 20: Systolic BP | 4.3 mmHg | Standard Deviation 7.68 |
| Placebo: Sitting | Change in Blood Pressure | Day 21: Diastolic BP | 8.5 mmHg | Standard Deviation 3.42 |
| Placebo: Sitting | Change in Blood Pressure | Day 21: Systolic BP | 11.8 mmHg | Standard Deviation 11.12 |
| Placebo: Sitting | Change in Blood Pressure | Day 22: Diastolic BP | 4.3 mmHg | Standard Deviation 3.72 |
| Placebo: Sitting | Change in Blood Pressure | Day 26: Diastolic BP | 9.3 mmHg | Standard Deviation 7.46 |
| Placebo: Sitting | Change in Blood Pressure | Day 26: Systolic BP | 8.5 mmHg | Standard Deviation 19.28 |
| Placebo: Sitting | Change in Blood Pressure | Day 27: Diastolic BP | 4.8 mmHg | Standard Deviation 4.67 |
| Placebo: Sitting | Change in Blood Pressure | Day 27: Systolic BP | 7.7 mmHg | Standard Deviation 8.16 |
| Placebo: Sitting | Change in Blood Pressure | Day 28: Diastolic BP | 11 mmHg | Standard Deviation 7.07 |
| Placebo: Sitting | Change in Blood Pressure | Day 28: Systolic BP | 22 mmHg | Standard Deviation 7.07 |
| Placebo: Sitting | Change in Blood Pressure | Day 29: Diastolic BP | -0.5 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 29: Systolic BP | 18 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 30: Diastolic BP | -1.5 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 30: Systolic BP | 8 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 34: Diastolic BP | 0.5 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 34: Systolic BP | 12.5 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 37: Diastolic BP | 0 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 37: Systolic BP | -5 mmHg | — |
| Placebo: Sitting | Change in Blood Pressure | Day 22: Systolic BP | 9.7 mmHg | Standard Deviation 16.02 |
| Placebo: Sitting | Change in Blood Pressure | Day 23: Diastolic BP | 3.5 mmHg | Standard Deviation 5.45 |
| Placebo: Sitting | Change in Blood Pressure | Day 23: Systolic BP | 11.5 mmHg | Standard Deviation 12.23 |
| Placebo: Sitting | Change in Blood Pressure | Day 24: Diastolic BP | 6.3 mmHg | Standard Deviation 4.5 |
| Placebo: Sitting | Change in Blood Pressure | Day 25: Diastolic BP | 4.7 mmHg | Standard Deviation 3.56 |
| Placebo: Sitting | Change in Blood Pressure | Day 25: Systolic BP | 8.5 mmHg | Standard Deviation 9.57 |
| Placebo: Standing | Change in Blood Pressure | Day 15: Systolic BP | 4.3 mmHg | Standard Deviation 13.01 |
| Placebo: Standing | Change in Blood Pressure | Day 15: Diastolic BP | 3.3 mmHg | Standard Deviation 7.77 |
| Placebo: Standing | Change in Blood Pressure | Day 1: Systolic BP | -0.3 mmHg | Standard Deviation 1.53 |
| Placebo: Standing | Change in Blood Pressure | Day 22: Systolic BP | 16 mmHg | Standard Deviation 1.41 |
| Placebo: Standing | Change in Blood Pressure | Day 8: Systolic BP | 3 mmHg | Standard Deviation 11 |
| Placebo: Standing | Change in Blood Pressure | Day 37: Systolic BP | -5 mmHg | — |
| Placebo: Standing | Change in Blood Pressure | Day 8: Diastolic BP | 5.3 mmHg | Standard Deviation 5.86 |
| Placebo: Standing | Change in Blood Pressure | Day 1: Diastolic BP | -0.7 mmHg | Standard Deviation 3.21 |
| Placebo: Standing | Change in Blood Pressure | Day 3: Systolic BP | 6 mmHg | Standard Deviation 7.94 |
| Placebo: Standing | Change in Blood Pressure | Day 28: Diastolic BP | 7.5 mmHg | Standard Deviation 4.95 |
| Placebo: Standing | Change in Blood Pressure | Day 3: Diastolic BP | 5 mmHg | Standard Deviation 6 |
| Placebo: Standing | Change in Blood Pressure | Day 22: Diastolic BP | 10 mmHg | Standard Deviation 1.41 |
| Placebo: Standing | Change in Blood Pressure | Day 37: Diastolic BP | 3 mmHg | — |
| Placebo: Standing | Change in Blood Pressure | Day 28: Systolic BP | 15.5 mmHg | Standard Deviation 14.85 |
Primary
Change in Pulse
Time frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Population: A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. Orthostatic vital signs only collected in clinic.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Pulse | Day 7 | 0 bpm | — |
| Lofexidine | Change in Pulse | Day 3 | -4 bpm | — |
| Lofexidine | Change in Pulse | Day 8 | -2 bpm | — |
| Lofexidine | Change in Pulse | Day 14 | -1 bpm | — |
| Lofexidine | Change in Pulse | Day 24 | -1 bpm | — |
| Lofexidine | Change in Pulse | Day 15 | -2 bpm | — |
| Lofexidine | Change in Pulse | Day 26 | 0.5 bpm | — |
| Lofexidine | Change in Pulse | Day 1 | 1 bpm | — |
| Lofexidine | Change in Pulse | Day 22 | -4 bpm | — |
| Lofexidine | Change in Pulse | Day 2 | -2 bpm | — |
| Lofexidine | Change in Pulse | Day 23 | 0.5 bpm | — |
| Placebo | Change in Pulse | Day 8 | -4 bpm | — |
| Placebo | Change in Pulse | Day 3 | -5 bpm | — |
| Placebo | Change in Pulse | Day 15 | 0 bpm | — |
| Placebo | Change in Pulse | Day 22 | -5 bpm | — |
| Placebo | Change in Pulse | Day 1 | 0 bpm | — |
| Placebo: Sitting | Change in Pulse | Day 22 | -6 bpm | Standard Deviation 4.1 |
| Placebo: Sitting | Change in Pulse | Day 23 | -4 bpm | Standard Deviation 11.8 |
| Placebo: Sitting | Change in Pulse | Day 24 | -6.5 bpm | Standard Deviation 4.2 |
| Placebo: Sitting | Change in Pulse | Day 25 | -0.8 bpm | Standard Deviation 7.78 |
| Placebo: Sitting | Change in Pulse | Day 26 | -9 bpm | Standard Deviation 4.97 |
| Placebo: Sitting | Change in Pulse | Day 28 | -7.5 bpm | Standard Deviation 3.54 |
| Placebo: Sitting | Change in Pulse | Day 27 | -5.5 bpm | Standard Deviation 7.31 |
| Placebo: Sitting | Change in Pulse | Day 29 | 3.5 bpm | — |
| Placebo: Sitting | Change in Pulse | Day 30 | 1.5 bpm | — |
| Placebo: Sitting | Change in Pulse | Day 34 | 2.5 bpm | — |
| Placebo: Sitting | Change in Pulse | Day 37 | -13 bpm | — |
| Placebo: Sitting | Change in Pulse | Day 2 | -9 bpm | Standard Deviation 4.24 |
| Placebo: Sitting | Change in Pulse | Day 3 | -7.3 bpm | Standard Deviation 2.63 |
| Placebo: Sitting | Change in Pulse | Day 7 | -2 bpm | Standard Deviation 9.54 |
| Placebo: Sitting | Change in Pulse | Day 8 | -1 bpm | Standard Deviation 3.46 |
| Placebo: Sitting | Change in Pulse | Day 1 | -5 bpm | Standard Deviation 2.65 |
| Placebo: Sitting | Change in Pulse | Day 14 | -1.7 bpm | Standard Deviation 7.09 |
| Placebo: Sitting | Change in Pulse | Day 15 | -11 bpm | Standard Deviation 8.19 |
| Placebo: Sitting | Change in Pulse | Day 18 | 1.7 bpm | Standard Deviation 2.89 |
| Placebo: Sitting | Change in Pulse | Day 19 | -2.8 bpm | Standard Deviation 4.03 |
| Placebo: Sitting | Change in Pulse | Day 20 | -8.8 bpm | Standard Deviation 5.12 |
| Placebo: Sitting | Change in Pulse | Day 21 | -1.8 bpm | Standard Deviation 8.54 |
| Placebo: Standing | Change in Pulse | Day 37 | -8 bpm | — |
| Placebo: Standing | Change in Pulse | Day 1 | -0.3 bpm | Standard Deviation 3.21 |
| Placebo: Standing | Change in Pulse | Day 3 | -5.3 bpm | Standard Deviation 0.58 |
| Placebo: Standing | Change in Pulse | Day 8 | -0.7 bpm | Standard Deviation 0.58 |
| Placebo: Standing | Change in Pulse | Day 15 | -3 bpm | Standard Deviation 3.46 |
| Placebo: Standing | Change in Pulse | Day 28 | -7 bpm | Standard Deviation 11.31 |
| Placebo: Standing | Change in Pulse | Day 22 | -7 bpm | Standard Deviation 2.83 |
Primary
Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation
Time frame: Day 1 through Day 28
Population: There were zero Treatment Emergent AE's.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lofexidine | Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation | 0 Participants |
| Placebo | Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation | 1 Participants |
Primary
Number of Treatment Emergent AEs and SAEs
Time frame: Day 1 through Day 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lofexidine | Number of Treatment Emergent AEs and SAEs | Adverse Events | 0 participants |
| Lofexidine | Number of Treatment Emergent AEs and SAEs | Serious Adverse Events | 0 participants |
| Placebo | Number of Treatment Emergent AEs and SAEs | Adverse Events | 5 participants |
| Placebo | Number of Treatment Emergent AEs and SAEs | Serious Adverse Events | 0 participants |
Primary
Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale
The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains yes or no questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a yes in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds yes to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.
Time frame: Day 1 through Day 28
Population: All responses were No.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lofexidine | Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale | 0 % of subjects with suicide risk |
| Placebo | Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale | 0 % of subjects with suicide risk |
Primary
Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests
Time frame: Day 1 through Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lofexidine | Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests | 0 Participants |
| Placebo | Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests | 0 Participants |
Secondary
Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)
A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Baseline through Follow-up (assessed daily)
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -2 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 37 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -0.5 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 40 | 1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 43 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 29 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -3 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 45 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 31 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 47 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 48 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 32 | 0 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 51 | -1 score on a scale | — |
| Lofexidine | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | 0 score on a scale | — |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | -0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | -0.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 26 | -1 score on a scale | Standard Deviation 2 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | 0 score on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 28 | -0.5 score on a scale | Standard Deviation 1.73 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 29 | 0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 30 | -0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 31 | -0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 32 | -1.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 33 | -2 score on a scale | — |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 34 | -0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 35 | -1 score on a scale | Standard Deviation 1 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 36 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 37 | -0.8 score on a scale | Standard Deviation 0.5 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 38 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 39 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 40 | -1.3 score on a scale | Standard Deviation 2.08 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 41 | -1 score on a scale | — |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 42 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 43 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 44 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 45 | -0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 46 | -0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 48 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 49 | -0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 50 | -0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 47 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 51 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | -0.3 score on a scale | Standard Deviation 0.82 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -1.5 score on a scale | Standard Deviation 1 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | -1.4 score on a scale | Standard Deviation 1.82 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 4 | -0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -1.3 score on a scale | Standard Deviation 1.15 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 6 | -1 score on a scale | Standard Deviation 1 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -0.7 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | -0.8 score on a scale | Standard Deviation 2.63 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 9 | -1 score on a scale | Standard Deviation 0.82 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -0.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 11 | -0.3 score on a scale | Standard Deviation 1.15 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -1 score on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -1 score on a scale | Standard Deviation 2 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1.3 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -0.8 score on a scale | Standard Deviation 1.5 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 16 | -1 score on a scale | Standard Deviation 0 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 17 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 18 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 19 | -0.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 20 | 0 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 21 | -1.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 22 | -1.2 score on a scale | Standard Deviation 1.83 |
| Placebo | Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 23 | 0 score on a scale | Standard Deviation 1.41 |
Secondary
Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Day 1 through Day 28 (assessed daily)
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | -0.5 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -13 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | 0 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -1 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | -2 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -1 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 28 | 1 units on a scale | — |
| Lofexidine | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 units on a scale | — |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -2 units on a scale | Standard Deviation 2.31 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 16 | -0.5 units on a scale | Standard Deviation 2.38 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 17 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 18 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 19 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 20 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 21 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 22 | -2 units on a scale | Standard Deviation 2.28 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 23 | 0 units on a scale | Standard Deviation 1.41 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | -1.7 units on a scale | Standard Deviation 3.06 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | -2.5 units on a scale | Standard Deviation 2.12 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 26 | -1.7 units on a scale | Standard Deviation 3.06 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | -1.5 units on a scale | Standard Deviation 0.71 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 28 | -1.5 units on a scale | Standard Deviation 1.91 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 units on a scale | Standard Deviation 0 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -1.3 units on a scale | Standard Deviation 1.89 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | -1.4 units on a scale | Standard Deviation 2.51 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 4 | -0.3 units on a scale | Standard Deviation 3.21 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -1 units on a scale | Standard Deviation 2.65 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 6 | -0.3 units on a scale | Standard Deviation 3.21 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -0.7 units on a scale | Standard Deviation 2.89 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | -1.8 units on a scale | Standard Deviation 3.2 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 9 | -0.5 units on a scale | Standard Deviation 3 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 11 | -1 units on a scale | Standard Deviation 2.65 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -2 units on a scale | Standard Deviation 2.83 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -1.3 units on a scale | Standard Deviation 3.21 |
| Placebo | Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 units on a scale | Standard Deviation 2.65 |
Secondary
Change in Clinical Opiate Withdrawal Scale (COWS)
The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.
Time frame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 8 | 3 score on a scale | — |
| Lofexidine | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 22 | -1 score on a scale | — |
| Lofexidine | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 15 | 4 score on a scale | — |
| Lofexidine | Change in Clinical Opiate Withdrawal Scale (COWS) | End of Study | -1 score on a scale | — |
| Lofexidine | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 3 | 2 score on a scale | — |
| Placebo | Change in Clinical Opiate Withdrawal Scale (COWS) | End of Study | -2.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 3 | -0.7 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 8 | -1 score on a scale | Standard Deviation 2 |
| Placebo | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 15 | -1.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Clinical Opiate Withdrawal Scale (COWS) | Day 22 | -2.5 score on a scale | Standard Deviation 0.71 |
Secondary
Change in Daily Opioid Dose as a Percentage of the Baseline MED
Time frame: Baseline through Day 28
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 1 | -50 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 2 | -50 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 3 | -50 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 4 | -50 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 5 | -50 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 7 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 8 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 10 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 11 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 12 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 20 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 24 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 25 | -75 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 27 | -50 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 8 | -52.1 MME (morphine milligram equivalent) | Standard Deviation 21.95 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 9 | -74.2 MME (morphine milligram equivalent) | Standard Deviation 1.44 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 22 | -7.5 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 10 | -56.3 MME (morphine milligram equivalent) | Standard Deviation 26.52 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 23 | -10 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 11 | -66.7 MME (morphine milligram equivalent) | Standard Deviation 14.43 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 1 | -50 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 28 | -10 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 2 | -50 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 12 | -75 MME (morphine milligram equivalent) | Standard Deviation 0 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 3 | -50 MME (morphine milligram equivalent) | Standard Deviation 0 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 13 | -66.7 MME (morphine milligram equivalent) | Standard Deviation 14.43 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 4 | -50 MME (morphine milligram equivalent) | Standard Deviation 0 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 14 | -72.5 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 5 | -51.7 MME (morphine milligram equivalent) | Standard Deviation 2.89 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 6 | -58.3 MME (morphine milligram equivalent) | Standard Deviation 14.43 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 16 | -77.5 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 7 | -65 MME (morphine milligram equivalent) | Standard Deviation 17.32 |
| Placebo | Change in Daily Opioid Dose as a Percentage of the Baseline MED | Day 24 | -10 MME (morphine milligram equivalent) | — |
Secondary
Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)
Time frame: Baseline through Day 28
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 1 | -45 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 12 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 3 | -45 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 7 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 2 | -45 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 8 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 20 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 4 | -45 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 5 | -45 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 24 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 10 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 25 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 27 | -67.5 MME (morphine milligram equivalent) | — |
| Lofexidine | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 11 | -67.5 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 16 | -155 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 22 | -15 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 23 | -20 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 24 | -20 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 4 | -63.3 MME (morphine milligram equivalent) | Standard Deviation 35.12 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 28 | -20 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 10 | -45 MME (morphine milligram equivalent) | Standard Deviation 0 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 1 | -100 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 2 | -30 MME (morphine milligram equivalent) | — |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 3 | -65 MME (morphine milligram equivalent) | Standard Deviation 49.5 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 5 | -66.7 MME (morphine milligram equivalent) | Standard Deviation 40.41 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 6 | -80 MME (morphine milligram equivalent) | Standard Deviation 62.45 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 7 | -75 MME (morphine milligram equivalent) | Standard Deviation 25.98 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 8 | -60.8 MME (morphine milligram equivalent) | Standard Deviation 34.13 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 9 | -93.3 MME (morphine milligram equivalent) | Standard Deviation 50.08 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 11 | -78.3 MME (morphine milligram equivalent) | Standard Deviation 29.3 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 12 | -67.5 MME (morphine milligram equivalent) | Standard Deviation 31.82 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 13 | -78.3 MME (morphine milligram equivalent) | Standard Deviation 29.3 |
| Placebo | Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED) | Day 14 | -145 MME (morphine milligram equivalent) | — |
Secondary
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale
The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of 0 - I have no problems or I am not to a maximum of 5 - I am unable to or I am extremely. The dimensions are averaged together for a single score and the change in average score from baseline is recorded.
Time frame: Change from Baseline to EOS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lofexidine | Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale | -0.40 score on a scale | — |
| Placebo | Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale | -0.13 score on a scale | Standard Deviation 0.462 |
Secondary
Change in Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study.
Time frame: Change from End of Study to Baseline, up to 55 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lofexidine | Change in Hospital Anxiety and Depression Scale (HADS) | -2 score on a scale | — |
| Placebo | Change in Hospital Anxiety and Depression Scale (HADS) | -2.3 score on a scale | Standard Deviation 3.51 |
Secondary
Change in Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time frame: Change from baseline to Days 15 and End of Study, up to 55 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Insomnia Severity Index (ISI) | Day 15 | -1 score on a scale | — |
| Lofexidine | Change in Insomnia Severity Index (ISI) | EOS | -9 score on a scale | — |
| Placebo | Change in Insomnia Severity Index (ISI) | Day 15 | -4 score on a scale | Standard Deviation 3 |
| Placebo | Change in Insomnia Severity Index (ISI) | EOS | 1 score on a scale | Standard Deviation 1.73 |
Secondary
Change in Short Form Health Survey (SF-36) Scale
The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale. The final value reported is the average change in the averaged scale scores from baseline to end of study.
Time frame: Change from baseline to End of Study, up to 55 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lofexidine | Change in Short Form Health Survey (SF-36) Scale | -5 score on a scale | — |
| Placebo | Change in Short Form Health Survey (SF-36) Scale | -1.7 score on a scale | Standard Deviation 2.52 |
Secondary
Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)
The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.
Time frame: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Population: A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. All remaining blank fields had no data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 12 | -3 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 8 | -2.5 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 13 | 2 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 2 | -4 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 14 | 1 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 3 | -5 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 24 | -5 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 15 | 0.7 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 25 | -5 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 10 | 0 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 7 | -4 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 27 | -6 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 5 | -3 score on a scale | — |
| Lofexidine | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 28 | -3 score on a scale | — |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 15 | -3.5 score on a scale | Standard Deviation 1.29 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 16 | 4.3 score on a scale | Standard Deviation 9 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 17 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 18 | -3 score on a scale | Standard Deviation 0 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 19 | -3 score on a scale | Standard Deviation 0 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 20 | -3.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 21 | -4 score on a scale | Standard Deviation 0 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 22 | -2.8 score on a scale | Standard Deviation 1.3 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 23 | -3.3 score on a scale | Standard Deviation 2.08 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 24 | -2.3 score on a scale | Standard Deviation 2.89 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 25 | -4.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 26 | -3.3 score on a scale | Standard Deviation 2.52 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 27 | -4 score on a scale | Standard Deviation 0 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 28 | -3.8 score on a scale | Standard Deviation 1.89 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 2 | 0.3 score on a scale | Standard Deviation 3.77 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 3 | -1 score on a scale | Standard Deviation 4.3 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 4 | 2.3 score on a scale | Standard Deviation 5.51 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 5 | 3 score on a scale | Standard Deviation 6.24 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 6 | 3.3 score on a scale | Standard Deviation 8.02 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 7 | 0 score on a scale | Standard Deviation 5.66 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 8 | 1.8 score on a scale | Standard Deviation 6.3 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 9 | 3.5 score on a scale | Standard Deviation 7.59 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 10 | -1.5 score on a scale | Standard Deviation 3.54 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 11 | 0.7 score on a scale | Standard Deviation 6.35 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 12 | -4 score on a scale | Standard Deviation 0 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 13 | -0.3 score on a scale | Standard Deviation 8.14 |
| Placebo | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 14 | 0.7 score on a scale | Standard Deviation 8.96 |
| Unknown | Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H) | Day 1 | — score on a scale | — |
Secondary
Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)
The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.
Time frame: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Population: A pause patient in the Placebo group had their End of Study on Visit Day 37. All other participants completed their EOS by Day 28. All remaining blank fields had no data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 12 | 2 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 8 | 1.5 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 13 | 4 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 2 | 1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 14 | 5 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 3 | 1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 24 | -1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 15 | 2.7 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 25 | -1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 10 | 4 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 7 | 1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 27 | 1 score on a scale | — |
| Lofexidine | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 5 | 1 score on a scale | — |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 14 | -1 score on a scale | Standard Deviation 6.08 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 15 | -4.3 score on a scale | Standard Deviation 0.96 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 16 | 1.5 score on a scale | Standard Deviation 6.45 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 17 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 18 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 19 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 20 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 21 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 22 | -3.8 score on a scale | Standard Deviation 2.49 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 23 | -2.7 score on a scale | Standard Deviation 2.52 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 24 | -3 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 25 | -4.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 26 | -3 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 27 | -4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 28 | -3.8 score on a scale | Standard Deviation 2.87 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 2 | -0.5 score on a scale | Standard Deviation 3 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 3 | -2.2 score on a scale | Standard Deviation 3.56 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 4 | -0.7 score on a scale | Standard Deviation 5.03 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 5 | -0.3 score on a scale | Standard Deviation 5.51 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 6 | 0.3 score on a scale | Standard Deviation 5.03 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 7 | -2.5 score on a scale | Standard Deviation 3.54 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 8 | -1.4 score on a scale | Standard Deviation 4.72 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 9 | 2 score on a scale | Standard Deviation 6 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 10 | -4.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 11 | -0.3 score on a scale | Standard Deviation 6.35 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 12 | -4.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 13 | -1 score on a scale | Standard Deviation 6.08 |
| Unknown | Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G) | Day 1 | — score on a scale | — |
Secondary
Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Baseline through Day 51 (assessed daily)
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -0.5 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -3 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 40 | 1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -3 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 29 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 43 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | -0.5 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 30 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 45 | -2 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 31 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 47 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 48 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 32 | 0 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 51 | -1 score on a scale | — |
| Lofexidine | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 score on a scale | — |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | 0.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 26 | 0 score on a scale | Standard Deviation 1 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | 1.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 28 | 0.5 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 29 | 1.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 30 | 0.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 31 | 0.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 32 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 33 | 1 score on a scale | — |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 34 | 1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 35 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 36 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 37 | 0.5 score on a scale | Standard Deviation 1 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 38 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 39 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 40 | 0.7 score on a scale | Standard Deviation 1.15 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 41 | -1 score on a scale | — |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 42 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 43 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 44 | 1.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 45 | 1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 46 | 1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 47 | 2 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 48 | 1 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 49 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 50 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 51 | 1 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 score on a scale | Standard Deviation 0.63 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -0.8 score on a scale | Standard Deviation 0.96 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | 0.2 score on a scale | Standard Deviation 1.3 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 4 | 0 score on a scale | Standard Deviation 1 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | 0 score on a scale | Standard Deviation 1 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 6 | 0.7 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | 0.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | 0.3 score on a scale | Standard Deviation 0.96 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 9 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 11 | 1 score on a scale | Standard Deviation 1 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -0.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | 0.3 score on a scale | Standard Deviation 0.58 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 16 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 17 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 18 | 1.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 19 | 1.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 20 | 0.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 21 | -1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 22 | 0 score on a scale | Standard Deviation 0.89 |
| Placebo | Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS) | Day 23 | 0.5 score on a scale | Standard Deviation 0.71 |
Secondary
Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Day 1 through Day 28 (assessed daily)
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -2 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -2 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | 0.5 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | -3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | -3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -1.3 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | -4 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -4 score on a scale | — |
| Lofexidine | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | -2.5 score on a scale | — |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 15 | -2.8 score on a scale | Standard Deviation 0.96 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 16 | -0.8 score on a scale | Standard Deviation 2.06 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 17 | -3 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 18 | -2.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 19 | -2.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 20 | -3 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 21 | -3 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 22 | -2.7 score on a scale | Standard Deviation 1.97 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 23 | -1 score on a scale | Standard Deviation 2.83 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 24 | -2 score on a scale | Standard Deviation 2.65 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 25 | -2.5 score on a scale | Standard Deviation 0.71 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 26 | -2 score on a scale | Standard Deviation 2.65 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 27 | -0.5 score on a scale | Standard Deviation 3.54 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 3 | -1.6 score on a scale | Standard Deviation 1.82 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 28 | -0.5 score on a scale | Standard Deviation 1.73 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 1 | 0 score on a scale | Standard Deviation 0 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 2 | -2.3 score on a scale | Standard Deviation 1.53 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 4 | -0.7 score on a scale | Standard Deviation 2.89 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 5 | -1 score on a scale | Standard Deviation 1.73 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 6 | 0.3 score on a scale | Standard Deviation 1.15 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 7 | -1 score on a scale | Standard Deviation 2.65 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 8 | -1.8 score on a scale | Standard Deviation 2.06 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 9 | -0.8 score on a scale | Standard Deviation 2.36 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 10 | -3 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 11 | -1.7 score on a scale | Standard Deviation 2.52 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 12 | -3 score on a scale | Standard Deviation 1.41 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 13 | -2 score on a scale | Standard Deviation 3 |
| Placebo | Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS) | Day 14 | -1 score on a scale | Standard Deviation 1.73 |
Secondary
Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score
MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug. SEVERITY OF ILLNESS: 1. = No at all ill 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects SIDE EFFECTS INDEX: 1. = None, study drug is producing no side effects 2. = Do not significantly interfere with subject's functioning 3. = Significantly interferes with subject's functioning 4. = Outweighs therapeutic effect
Time frame: Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 3 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 2 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 4 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 5 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | EOS | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 4 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 2 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 3 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 5 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | EOS | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 3 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 4 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 2 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | EOS | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 5 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 2 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 5 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 4 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | EOS | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score | Visit 3 | 1.33 score on a scale | Standard Deviation 0.471 |
Secondary
Modified Clinical Global Impression - Subject Version (MCGI-S)
Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug. SEVERITY OF OPIATE WITHDRAWAL: 1. = No opiate withdrawal symptoms 2. = On the border between no to mild opiate withdrawal symptoms 3. = Mild opiate withdrawal symptoms 4. = Moderate opiate withdrawal symptoms 5. = Marked opiate withdrawal symptoms 6. = Severe opiate withdrawal symptoms 7. = The most severe opiate withdrawal symptoms that I have ever had SIDE EFFECTS INDEX (Scale B): 1. = None. The study drug has no side effects 2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities 3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities 4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides
Time frame: Each scheduled evaluation (Day 1 through Day 28)
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 24 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 10 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 27 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 3 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 25 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 8 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 5 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 12 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 14 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 7 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 15 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 13 | 1 score on a scale | — |
| Lofexidine | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 2 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 25 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 7 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 20 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 8 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 28 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 24 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 9 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 10 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 23 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 11 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 22 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 12 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 3 | 1 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 21 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 13 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 19 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 14 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 27 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 18 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 15 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 4 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 17 | 1.5 score on a scale | Standard Deviation 0.5 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 16 | 2 score on a scale | — |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 5 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 2 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 26 | 1.33 score on a scale | Standard Deviation 0.471 |
| Placebo | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 6 | 2 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 25 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 2 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 3 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 5 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 7 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 8 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 10 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 12 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 13 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 14 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 15 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 24 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 27 | 1 score on a scale | — |
| Placebo: Sitting | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 28 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 14 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 18 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 13 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 20 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 12 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 21 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 11 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 22 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 10 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 23 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 9 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 8 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 2 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 24 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 7 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 6 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 19 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 25 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 5 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 26 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 4 | 2 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 3 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 28 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 27 | 1 score on a scale | — |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 16 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 15 | 1.66 score on a scale | Standard Deviation 0.471 |
| Placebo: Standing | Modified Clinical Global Impression - Subject Version (MCGI-S) | Day 17 | 1.5 score on a scale | Standard Deviation 0.5 |
Secondary
Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day
Time frame: Day 1 through Day 28
Population: No data collection for field with 0 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lofexidine | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 1-15: | 0 Number concomitant medication |
| Lofexidine | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 16- Day 28: | 1 Number concomitant medication |
| Placebo | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 1-15: | 1 Number concomitant medication |
| Placebo | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 16- Day 28: | 1 Number concomitant medication |
| Placebo: Sitting | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 16- Day 28: | 1 Number concomitant medication |
| Placebo: Sitting | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 1-15: | 1 Number concomitant medication |
| Placebo: Standing | Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day | Day 1-15: | 1 Number concomitant medication |
Secondary
Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation
Time frame: Day 1 through Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lofexidine | Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation | 0 Participants |
| Placebo | Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation | 2 Participants |
Secondary
Time to Study Drug Discontinuation
Study day of participant discontinuation.
Time frame: Day 1 through Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lofexidine | Time to Study Drug Discontinuation | 21 Days to study discontinuation |
| Placebo | Time to Study Drug Discontinuation | 20 Days to study discontinuation |
| Placebo: Sitting | Time to Study Drug Discontinuation | 22 Days to study discontinuation |
| Placebo: Standing | Time to Study Drug Discontinuation | 24 Days to study discontinuation |