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Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

Active, not recruitingPhase 4NCT06367387
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial
Interventions
  • Drug: Patient-Oriented Dosing (POD)
  • Behavioral: Pain Self-Management (PSM)
  • Behavioral: Usual Care
  • Drug: Standard Buprenorphine Dosing Condition
Sponsor
Erin Winstanley
Collaborators
National Institute on Drug Abuse (NIDA)
Organization
University of Pittsburgh
Start date
2024-05-28
Primary completion
2026-02-09
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
13

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Adults at least 18 years old 2. Patient at a participating clinic 3. Ability to speak, read, and understand English 4. Capable of providing informed consent 5. Access to phone and/or internet 6. Documented diagnosis of Opioid Use Disorder (OUD) 7. On a stable dose of an oral or sublingual buprenorphine mono or combination product (\<4 times per day, daily dosage \<32 mg) for at least 7 days during incident new episode of care 8. Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Under 18 years of age 2. Have cancer-related pain 3. Are currently in jail, prison, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities 4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product 5. Currently prescribed an injectable formulation of buprenorphine 6. Pregnancy or intention to become pregnant within 4 months of enrollment 7. Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days 8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock 9. Currently prescribed/taking methadone or have taken methadone in the past 30 days 10. Had an intentional suicide attempt within the past 3 months Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06367387