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NCT06367387 · ClinicalTrials.gov registry record · Phase 4
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
A Phase 4 study of Chronic Pain and Opioid Use Disorder, sponsored by Erin Winstanley.
- Active
- Registry status
- Phase 4
- Development phase
- 268
- Enrollment target
- 13
- Study locations
NCT06367387: Active Phase 4 study of Chronic Pain and Opioid Use Disorder, sponsored by Erin Winstanley.
NCT06367387 is a Phase 4 study of Chronic Pain and Opioid Use Disorder that is active but no longer recruiting, run by Erin Winstanley. The registered enrollment target is 268 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (65% lower). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06367387, a Phase 4 study of Chronic Pain and Opioid Use Disorder, is active but no longer recruiting, sponsored by Erin Winstanley.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 268 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care: 1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain. 2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels. The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation. There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention.
Primary Outcome
The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (S
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- DRUG Patient-Oriented Dosing (POD)
- BEHAVIORAL Pain Self-Management (PSM)
- DRUG Standard Buprenorphine Dosing Condition
Study Locations (13)
Oregon
- Central City Concern (CCC) - Portland
- Recovery Works Northwest (RWNW) - Portland
- OHSU Harm Reduction Bridges to Care (HRBR) - Portland
- OHSU Internal Medicine Clinic (IMC) - Portland
Pennsylvania
- UPMC Latterman Family Health Center - McKeesport
- UPMC St. Margaret Family Health Center - New Kensington
- UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC) - Pittsburgh
- UPMC Internal Medicine Recovery Engagement Program (IM-REP) - Pittsburgh
Maryland
- Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center - Baltimore
- MATClinics - Dundalk
- Wells House - Hagerstown
West Virginia
- WVU Crisis Support & Recovery Center - Martinsburg
- WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT) - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2024-05-28 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 4 |
What the registry record for NCT06367387 still lists
NCT06367387 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 4 interventions - of which Usual Care is the first listed.
NCT06367387 lists 13 locations in 4 states (Oregon, Pennsylvania, Maryland).
Frequently Asked Questions
What is clinical trial NCT06367387 about?
NCT06367387 is a clinical study titled "Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment". This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care: 1. Pain Self-Management (PSM): an educational program in which indi...
What is the current status of trial NCT06367387?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 268 participants. The study started on 2024-05-28. Estimated completion is 2026-10-31.
What conditions does trial NCT06367387 study?
This clinical trial studies the following conditions: Chronic Pain, Opioid Use Disorder.
What interventions are being tested in trial NCT06367387?
The interventions under investigation include: Usual Care (BEHAVIORAL), Patient-Oriented Dosing (POD) (DRUG), Pain Self-Management (PSM) (BEHAVIORAL), Standard Buprenorphine Dosing Condition (DRUG).
Who is sponsoring clinical trial NCT06367387?
This trial is sponsored by Erin Winstanley, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06367387 being conducted?
This trial has 13 study locations across Maryland, Oregon, Pennsylvania, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06367387's enrollment target sits among peer trials
268 60th of 301 higher than 241 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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