Chronic PainNCT03890263
Evaluating Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention
A study testing Chronic Pain Self-Management Support in people with Chronic Pain, run by Queen's University at 1 site in Canada.
Trial summary
This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Chronic Pain Self-Management Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 28 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain for >3months
- On opioid medications with a dose of at least 50 milligram morphine equivalents per day
- Ability to communicate effectively using the English language, including reading and writing
Who cannot join
- Chronic pain due to cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Outcomes and Experiences of Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention: a Mixed Methods Study
This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach
Read the detailed description
Chronic pain is a burden on individuals, the health system, and society. Opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. Unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. Opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. One of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids.
Unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. Self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. Evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach. If effective, this approach could be implemented more widely. The results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic pain.
- Conditions
- Chronic Pain
- Being tested
- Chronic Pain Self-Management Support
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Pain Self-Management SupportBehavioural
Also called Opioid De-prescription
Family physicians and nurse practitioners will participate in an academic detailing session with a pharmacist that focuses on safe, evidence-based opioid deprescribing. The pharmacist will provide pre-visit recommendations for each visit with a person on high doses of opioids. The pharmacist and healthcare providers will develop a patient centered, opioid taper schedule, with follow-up at 2 to 4 week intervals to assess for efficacy and safety.
The self-management intervention will be "Chronic Pain Self-management Support with Pain Science Education and Exercise" (COMMENCE), which consists of 2 visits per week over 6 weeks. One visit per week is 1.5 hours in a group format. with education about self-management and pain science as well as cognitive behavioural principles. The 2nd visit each week is 30 minutes in a one-to-one format and is individually tailored to support implementation of self-management plans and development of an exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Opioid deprescribing and self-management | Experimental | Not described Receives: Behavioral: Chronic Pain Self-Management Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Opioid Use
Changes in opioid use will be measured using milligram morphine equivalents per day. This will be collected every two weeks throughout the 36-week study period.
Measured: Every 2 weeks for 36 weeks
Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI)
Changes in pain severity will be measured using the Pain Severity Scale of the Brief Pain Inventory (BPI), which asks about the participant's pain at its worst, at its best, on overage and right now. It uses an 11-point scale ranging from 0 to 10, where 0 indicates no pain at all and 10 indicates the worst pain imaginable. The mean severity of all four individual scores will be used for the main analysis (total of all four scores divided by four). Pain severity will be assessed every two weeks, measuring the change across the course of the study.
Measured: Every 2 weeks for 36 weeks
Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI)
Changes in pain interference will be measured with the Pain Interference Scale of the Brief Pain Inventory (BPI), which uses an 11-point scale to measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. On the scale, 0 indicates that pain has not interfered with the activity at all and 10 indicates that pain has completely interfered with the activity. BPI Pain Interference will scored as the mean of the scores on seven interference items (total of all seven scores divided by seven). Pain interference will be assessed every two weeks, measuring the change across the course of the study.
Measured: Every 2 weeks for 36 weeks
Occurrence of Adverse Events
Occurrence adverse events over a 36 week period will be recorded using an adverse events questionnaire that is consistent with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) what adverse events were experienced (choose from a drop-down list or 'other'); 3) how long the event lasted (hours or days); 4) How severe the adverse event was (0-10 scale, where 0 indicates not severe at all and 10 indicates very severe). Each occurrence (the type of adverse event and duration and severity) will be recorded individually for reporting purposes as well as descriptive purposes.
Measured: Every 2 weeks for 36 weeks
Secondary outcomes (11)
Adverse Childhood Experiences (ACE) Questionnaire
The Adverse Childhood Experiences (ACE) Questionnaire will be used to identify adverse childhood experiences. It has shown good reliability and predictive validity. Several studies have demonstrated its ability to predict the onset of chronic pain in adults and it has been shown to be associated with initiation of opioid use, opioid dependence, opioid misuse, and likelihood of experiencing an opioid overdose. The questionnaire has 10 questions about various stressful childhood experiences. For each question an answer of No = 0 and and answer of Yes = 1. The total score out of 10 possible points will be used. This questionnaire will be administered only once at baseline.
Measured: Baseline
9-item Patient Health Questionnaire (PHQ-9)
The PHQ-9 demonstrates good reliability and validity and will be used to screen for depression using a cut-score of 10 points as has been suggested in the literature. The PHQ-9 has 9 questions, which all start with, "Over the past two weeks, how often have you been bothered by the following problem...:" The participant answers each one on a four-point Likert Scale, where 0 indicates not bothered at all and 3 indicates bothered nearly every day. The total score out of a possible 27 points will be used. This questionnaire will be administered only once at baseline to describe the population.
Measured: Baseline
Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version
The PTSD Checklist - Civilian Version will be used to identify the presence and severity of post-traumatic stress symptoms. The checklist has 17 questions. The instructions begin with: "Below is a list of problems and complaints that people sometimes have in response to stressful life experiences. Please read each one carefully, then pick the answer that indicates how much you have been bothered by that problem in the last month." The answers are on a five-point scale, where 1 indicates not bothered at all and 5 indicates extremely bothered. The total severity score out of a possible 85 points will be used. A score range of 17-29 shows little to no severity; a score range of 28-29 shows some PTSD symptoms; a score range of 30-44 shows moderate to moderately high severity of PTSD symptoms; and a score range of 45-85 shows high severity of PTSD symptoms. This questionnaire will be administered only once at baseline to describe the population
Measured: Baseline
Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L)
Health-related quality of life will be measured with the EuroQOL-5D (EQ-5D-5L). This questionnaire has two parts: the first is the 5-question 'descriptive system', which asks respondents to 'select the ONE statement that BEST describes your health TODAY' for 5 health dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. The 5 statements for each dimension are "no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5)". The 5 answers form a 5-digit code describing the respondent's 'health state'. Eg. the health state '12345' indicates no problems with mobility, slight problems with washing/dressing, moderate problems with usual activities, severe pain or discomfort and extreme anxiety or depression.
The second part asks respondents to rate their global health today on a visual analogue scale from 0-100, where 100 means the best health imaginable and 0 means the worst health imaginable.
Measured: Baseline
Change in patient specific functional scale (PSFS)
Changes in function will be measured with the Patient-Specific Functional Scale. Participants are asked to identify three important activities that they are having difficulty doing or are unable to do as a result of their primary condition. For each activity, they are asked to use an 11-point scale to rate their difficulty, where 0 indicates they are able to perform activity at the same level as before the injury or problem (No issues) and 10 indicates they are unable to perform activity (Cannot perform). The mean score will be used (sum of the activity scores divided by the number of activities). Minimum detectable change (90%CI) for average score = 2 points. The same activities will be rated at baseline, 12 weeks and 36 weeks, and the changes in mean scores between time points will be recorded.
Measured: Baseline, 12 weeks, 36 weeks
Global Rating of Change in function (12-weeks)
Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points.
Measured: 12-weeks
Global Rating of Change in function (36-weeks)
Changes in Global Rating of Change in Functional Abilities will be measured using an 11-point scale ranging from -5 (much worse) to +5 (completely recovered) as has been recommended in the literature for self-reported rating of change. This will be measured at 12 weeks and 36 weeks, recording the change across time points.
Measured: 36 weeks
Goal Attainment Scale (12-weeks)
Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks.
Measured: 12-weeks
Goal Attainment Scale (36-weeks)
Changes in the attainment of three stated functional goals will be measured using the Goal Attainment Scale. This is a 5-point scale, used to assess attainment of individual goals, ranging from -2 to +2, where -2 indicates a level of attainment much less than expected, 0 indicates the expected level of attainment, and +2 indicates a level of attainment much more than expected. The mean score will be used (sum of the attainment scores divided by the number of attainment scores). The goals will be identified at baseline and goal attainment will be measured at 12 weeks and 36 weeks.
Measured: 12-weeks and 36 weeks
Satisfaction with care (12-weeks): 11-point scale
Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. This will be measured this at 12 weeks and 36 weeks.
Measured: 12-weeks
Satisfaction with care (36-weeks): 11-point scale
Satisfaction with Care will be measured using an 11-point scale ranging from -5 (very dissatisfied) to +5 (very satisfied) as has been recommended in the literature for self-reported rating of change. We will measure this at 12 weeks and 36 weeks.
Measured: 36-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Jul 2019
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will use parallel mixed methods including: 1. An interrupted time series design to evaluate outcomes of an evidence-based self-management intervention and opioid deprescribing. This time series will include 18 assessments over 36-weeks from 12 weeks prior to implementation of the combined intervention to 24 weeks after implementation of the combined intervention. 2. Qualitative semi-structured interviews informed by an interpretive description approach with patients and health care providers to understand their perspectives and experiences. 3. A nested cross sectional evaluation to determine the characteristics of people who are identified on high doses of opioids in primary care in South Eastern Ontario. Characteristics collected will include: age, sex, gender, education, household income, postal code/geographic location, work status, caregiver status, early childhood trauma, depression, post-traumatic stress, health-related quality of life, and comorbidities.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jordan Miller, PT, PhD, Queen's University
- Investigators
- Jordan Miller, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890263
- Sponsor's protocol ID
- 373022
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Outcomes and Experiences of Chronic Pain Self-Management Support with an Opioid De-prescribing Intervention: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT03890263
- Acronym / sponsor ID
- 373022
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach
Detailed description
Chronic pain is a burden on individuals, the health system, and society. Opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. Unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. Opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. One of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids.
Unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. Self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. Evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. This study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach. If effective, this approach could be implemented more widely. The results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use parallel mixed methods including: 1. An interrupted time series design to evaluate outcomes of an evidence-based self-management intervention and opioid deprescribing. This time series will include 18 assessments over 36-weeks from 12 weeks prior to implementation of the combined intervention to 24 weeks after implementation of the combined intervention. 2. Qualitative semi-structured interviews informed by an interpretive description approach with patients and health care providers to understand their perspectives and experiences. 3. A nested cross sectional evaluation to determine the characteristics of people who are identified on high doses of opioids in primary care in South Eastern Ontario. Characteristics collected will include: age, sex, gender, education, household income, postal code/geographic location, work status, caregiver status, early childhood trauma, depression, post-traumatic stress, health-related quality of life, and comorbidities.
| Arm | Type | Receives |
|---|---|---|
| Opioid deprescribing and self-management | Experimental | Behavioral: Chronic Pain Self-Management Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain for >3months
- On opioid medications with a dose of at least 50 milligram morphine equivalents per day
- Ability to communicate effectively using the English language, including reading and writing
Key exclusion criteria (1 listed)
- Chronic pain due to cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Pain Self-Management SupportAlso: Opioid De-prescriptionFamily physicians and nurse practitioners will participate in an academic detailing session with a pharmacist that focuses on safe, evidence-based opioid deprescribing. The pharmacist will provide pre-visit recommendations for each visit with a person on high doses of opioids. The pharmacist and healthcare providers will develop a patient centered, opioid taper schedule, with follow-up at 2 to 4 week intervals to assess for efficacy and safety. The self-management intervention will be "Chronic Pain Self-management Support with Pain Science Education and Exercise" (COMMENCE), which consists of 2 visits per week over 6 weeks. One visit per week is 1.5 hours in a group format. with education about self-management and pain science as well as cognitive behavioural principles. The 2nd visit each week is 30 minutes in a one-to-one format and is individually tailored to support implementation of self-management plans and development of an exercise program. | Behavioural | Opioid deprescribing and self-management |
Primary outcome
Changes in Opioid Use
Time frame: Every 2 weeks for 36 weeks
Changes in opioid use will be measured using milligram morphine equivalents per day. This will be collected every two weeks throughout the 36-week study period.
Changes in Pain Severity: Pain Severity Scale of the Brief Pain Inventory (BPI)
Time frame: Every 2 weeks for 36 weeks
Changes in pain severity will be measured using the Pain Severity Scale of the Brief Pain Inventory (BPI), which asks about the participant's pain at its worst, at its best, on overage and right now. It uses an 11-point scale ranging from 0 to 10, where 0 indicates no pain at all and 10 indicates the worst pain imaginable. The mean severity of all four individual scores will be used for the main analysis (total of all four scores divided by four). Pain severity will be assessed every two weeks, measuring the change across the course of the study.
Changes in Pain Interference: Pain Interference Scale of the Brief Pain Inventory (BPI)
Time frame: Every 2 weeks for 36 weeks
Changes in pain interference will be measured with the Pain Interference Scale of the Brief Pain Inventory (BPI), which uses an 11-point scale to measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. On the scale, 0 indicates that pain has not interfered with the activity at all and 10 indicates that pain has completely interfered with the activity. BPI Pain Interference will scored as the mean of the scores on seven interference items (total of all seven scores divided by seven). Pain interference will be assessed every two weeks, measuring the change across the course of the study.
Occurrence of Adverse Events
Time frame: Every 2 weeks for 36 weeks
Occurrence adverse events over a 36 week period will be recorded using an adverse events questionnaire that is consistent with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) what adverse events were experienced (choose from a drop-down list or 'other'); 3) how long the event lasted (hours or days); 4) How severe the adverse event was (0-10 scale, where 0 indicates not severe at all and 10 indicates very severe). Each occurrence (the type of adverse event and duration and severity) will be recorded individually for reporting purposes as well as descriptive purposes.
11 secondary outcomes
Adverse Childhood Experiences (ACE) Questionnaire
Time frame: Baseline
9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline
Post-traumatic Stress Disorder (PTSD) Checklist - Civilian Version
Time frame: Baseline
Health-related Quality of Life: EuroQOL-5D (EQ-5D-5L)
Time frame: Baseline
Change in patient specific functional scale (PSFS)
Time frame: Baseline, 12 weeks, 36 weeks
Global Rating of Change in function (12-weeks)
Time frame: 12-weeks
Global Rating of Change in function (36-weeks)
Time frame: 36 weeks
Goal Attainment Scale (12-weeks)
Time frame: 12-weeks
Goal Attainment Scale (36-weeks)
Time frame: 12-weeks and 36 weeks
Satisfaction with care (12-weeks): 11-point scale
Time frame: 12-weeks
Satisfaction with care (36-weeks): 11-point scale
Time frame: 36-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Miller, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Pain Self-Management Support in people with Chronic Pain, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Opioid Use (time frame: Every 2 weeks for 36 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.