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Active Not Recruiting
NCT06367387
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
Conditions: Opioid Use Disorder, Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 273
Sponsor: Erin Winstanley
Location: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center Baltimore Maryland
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.
Eligibility Criteria
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 (\
Source: ClinicalTrials.gov (NCT06367387). StuddyBuddy aggregates publicly available trial information.