Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
Sponsor: Erin Winstanley
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.
Official title: Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2024-05-28
Completion Date
2026-10-31
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Patient-Oriented Dosing (POD)
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone to treat individuals with both OUD and chronic pain. It is based on existing evidence related to buprenorphine for the treatment of pain. POD allows participants to receive a daily dosage of bup up to 32mg/day, split up to 4 times per day. A response-guided dosing strategy, in which buprenorphine or buprenorphine/naloxone doses will be titrated based on a participant response, will be used to identify a dose regimen that is safe and effective. Due to inter-individual pharmacokinetic/pharmacodynamic variability, POD dosing will be individualized based on a participant's pain intensity and interference.
Pain Self-Management (PSM)
Pain self-management (PSM) is a manualized behavioral intervention consisting of 12 sessions, comprising 6 group and 6 individual sessions. The first session will be individual, followed by a group session, and then alternating weekly for the remainder of the intervention. Individual sessions will be led by a staff Interventionist trained in the pain self-management intervention. The interventionist will guide participants through a PSM study manual, providing education, teaching associated skills, and assisting with goal setting. Group sessions will be led by a Peer Facilitator who has experience with chronic pain, opioid use disorder, and buprenorphine treatment. These sessions will not have specific content but will serve as supportive forums for participants to discuss their experiences with the intervention, share tips for managing chronic pain, and provide mutual support.
Usual Care
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Standard Buprenorphine Dosing Condition
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Locations (13)
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