Chronic Pain, Deglutition, Opioid Use
Conditions
Keywords
Abuse-deterrent opioid drugs, Xtampza ER
Brief summary
This study will examine how the use of Xtampza ER, an opioid analgesic packaged in openable microsphere-containing capsules, affects swallowing satisfaction, pain, and physical and mental health outcomes in chronic pain patients.
Detailed description
An important step in the evolution of pain care is more personalized medicine. One aspect of personalized medicine emphasizes that patients often have additional requirements for prescription medicines beyond just pain relief, including ease in taking medications and overall satisfaction with their care. Surveys indicate that 20% of adult patients either with or without pain have difficulty swallowing their medications, and up to 10% refuse to take a specific therapy because they cannot swallow the pills \[1-3\]. It is likely that this issue compromises the quantity, quality, and satisfaction with pain relief from oral opioids. Xtampza ER is an opioid analgesic consisting of a microsphere-containing capsule that can be opened so the microspheres can be added to soft food. This drug is designed to overcome capsule-swallowing issues and therefore may be an important tool for personalized pain medicine care. This study will investigate the pharmaceutic delivery properties of Xtampza to determine whether it is an improved alternative to the pill-swallowing problems that are common with opioid drugs.
Interventions
DRUGXtampza ER (oxycodone)
Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.
Sponsors
Collegium Pharmaceutical, Inc.
Ajay Wasan, MD, Msc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult subjects must have noncancer chronic pain for at least six months on a daily basis, 2. Be prescribed opioids on a daily basis 3. Have an upper dose limit of daily opioids of 200 mg of morphine equivalents. This is because at doses greater than 200 mg daily, in the investigator's experience it is much more difficult to convert completely to another opioid compound within a week. Fentanyl and methadone users will not be specifically excluded unless their dosages fall outside this range. 4. Ages 21-70 5. Reported difficulty swallowing their opioid medication on the screening form at a level determined significant by the PI. 6. Having a mobile phone. A smart phone is not required to respond to the text messages. 7. Having Internet access to be able to respond to the emailed weekly surveys. 8. If sexually active and able to become pregnant, must agree to use an acceptable method of birth control (hormonal methods, barrier methods with spermicide, intrauterine device (IUD) or abstinence). 9. Only Pain Medicine Clinic patients may participate in this study
Exclusion criteria
1. Inability to understand the surveys and complete them. 2. Pregnancy 3. High risk for opioid addiction and/or abuse behaviors 4. Any condition, physical or mental, that in the investigator's judgment precludes optimal participation in the study procedures. This includes any documented current history of liver disease, renal insufficiency, delirium, alcohol use disorder, breast-feeding mothers, acute or severe asthma, chronic obstructive pulmonary disease requiring home oxygen, GI obstruction, biliary tract disease, pancreatitis, cardiac arrhythmia, bladder or urethral obstruction, adrenal insufficiency, psychosis, or taking medications which are potent inhibitors of the CYP3A4 enzyme (such as protease inhibitors, macrolide antibiotics, or antifungals). 5. Demonstration of abusive alcohol behavior. For women, this is more than 3 drinks on any single day or more than 7 drinks per week. For men, more than 4 drinks on any single day or more than 14 drinks per week. 6. Currently taking fentanyl or methadone 7. Exhibiting the following contraindicated conditions: (1) significant respiratory depression (2) acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (3) known or suspected gastrointestinal obstruction, including paralytic ileus (4) hypersensitivity (e.g. anaphylaxis) to oxycodone (5) patients with chronic pulmonary disease (6) elderly, cachet, or debilitated patients (7) patients with evidence of increased intracranial pressure, brain tumors, head injury, or impaired consciousness (8) patients with seizure disorders (9) pregnant and breastfeeding women, due to risks to the fetus/baby
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours | Measured at baseline and at the end of the 6-week study | Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score. |
| Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days | Measured at baseline and at the end of the 6-week study | Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Medication Satisfaction | Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER. | Opioid medication satisfaction will be measured via a 0-10 scale with 0 being not satisfied at all and 10 being completely satisfied. Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6). |
| PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance | Measured at baseline and at the end of the 6-week study | The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Never and 5 being Always. Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6). |
| Change in Pill Swallowing Difficulty Score | Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER. | Pill swallowing difficulty will be measured via a 0-10 scale with 0 being no trouble at all and 10 being the greatest difficulty possible. Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6). |
| Patient Global Impression of Change (PGIC) | Recorded in week 6. | The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6). |
| PROMIS Physical Function | Measured at baseline and at the end of the 6-week study | The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being Without any difficulty and 1 being Unable to do. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6). |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Measured at baseline and at the end of the 6-week study | The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Not at all and 5 being Very much. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xtampza ER (Oxycodone) Treatment Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.
Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Xtampza ER (Oxycodone) Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 8.6 |
| Daily Pain Intensity | 8.1 units on a scale STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Opioid medication satisfaction | 4.3 units on a scale STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
| Swallowing Difficulty | 6.7 units on a scale STANDARD_DEVIATION 1.8 |
| Weekly Pain Intensity | 8.0 units on a scale STANDARD_DEVIATION 2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours
Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time frame: Measured at baseline and at the end of the 6-week study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours | 12.5 percent change | Standard Deviation 31.5 |
p-value: 0.218ANOVA
Primary
Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days
Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time frame: Measured at baseline and at the end of the 6-week study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days | 9.3 percent change | Standard Deviation 30 |
p-value: 0.268ANOVA
Secondary
Change in Pill Swallowing Difficulty Score
Pill swallowing difficulty will be measured via a 0-10 scale with 0 being no trouble at all and 10 being the greatest difficulty possible. Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Change in Pill Swallowing Difficulty Score | -5.7 units on a scale | Standard Deviation 2.6 |
p-value: <0.001ANOVA
Secondary
Opioid Medication Satisfaction
Opioid medication satisfaction will be measured via a 0-10 scale with 0 being not satisfied at all and 10 being completely satisfied. Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Opioid Medication Satisfaction | 2.8 units on a scale | Standard Deviation 4 |
p-value: 0.043ANOVA
Secondary
Patient Global Impression of Change (PGIC)
The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6).
Time frame: Recorded in week 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Patient Global Impression of Change (PGIC) | 1.2 units on a scale | Standard Deviation 1.1 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Not at all and 5 being Very much. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | -3.6 T-Score | Standard Deviation 8.2 |
p-value: 0.228ANOVA
Secondary
PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance
The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Never and 5 being Always. Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance | Anxiety | -1.7 T-Score | Standard Deviation 6.1 |
| Xtampza ER (Oxycodone) Treatment | PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance | Depression | -0.4 T-Score | Standard Deviation 7.3 |
| Xtampza ER (Oxycodone) Treatment | PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance | Satisfaction with Social Roles | 1.1 T-Score | Standard Deviation 4.9 |
| Xtampza ER (Oxycodone) Treatment | PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance | Sleep Disturbance | -3.7 T-Score | Standard Deviation 6.2 |
Comparison: PROMIS Social Roles scorep-value: 0.486ANOVA
Comparison: PROMIS Sleep Disturbance T-Scoresp-value: 0.078ANOVA
Comparison: PROMIS Depression T-Scoresp-value: 0.874ANOVA
Comparison: PROMIS Anxiety T-Scorep-value: 0.389ANOVA
Secondary
PROMIS Physical Function
The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being Without any difficulty and 1 being Unable to do. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xtampza ER (Oxycodone) Treatment | PROMIS Physical Function | 0.7 T-Score | Standard Deviation 5 |
p-value: 0.676ANOVA