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

Running, not enrolling · Phase 4

Conditions studied: Opioid Use Disorder, Chronic Pain

In brief

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.

Key facts

Study ID

NCT06367387

Run by

Erin Winstanley

People needed

268

Starts

2024-05-28

Expected to finish

2026-10-31

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Adults at least 18 years old
• Patient at a participating clinic
• Ability to speak, read, and understand English
• Capable of providing informed consent
• Access to phone and/or internet
• Documented diagnosis of Opioid Use Disorder (OUD)
• 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
• Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Under 18 years of age
• Have cancer-related pain
• 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
• Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
• Currently prescribed an injectable formulation of buprenorphine
• Pregnancy or intention to become pregnant within 4 months of enrollment
• Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
• History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
• Currently prescribed/taking methadone or have taken methadone in the past 30 days
• 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.

Where it is running

• Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center — Baltimore, Maryland, United States
• MATClinics — Dundalk, Maryland, United States
• Wells House — Hagerstown, Maryland, United States
• Central City Concern (CCC) — Portland, Oregon, United States
• Recovery Works Northwest (RWNW) — Portland, Oregon, United States
• OHSU Harm Reduction Bridges to Care (HRBR) — Portland, Oregon, United States
• OHSU Internal Medicine Clinic (IMC) — Portland, Oregon, United States
• UPMC Latterman Family Health Center — McKeesport, Pennsylvania, United States
• UPMC St. Margaret Family Health Center — New Kensington, Pennsylvania, United States
• UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC) — Pittsburgh, Pennsylvania, United States
• UPMC Internal Medicine Recovery Engagement Program (IM-REP) — Pittsburgh, Pennsylvania, United States
• WVU Crisis Support & Recovery Center — Martinsburg, West Virginia, United States
• WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT) — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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