268
Participants
Start Date
May 28, 2024
Primary Completion Date
January 31, 2026
Study Completion Date
October 31, 2026
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.
RECRUITING
UPMC St. Margaret Family Health Center, New Kensington
RECRUITING
UPMC Latterman Family Health Center, McKeesport
RECRUITING
UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC), Pittsburgh
RECRUITING
UPMC Internal Medicine Recovery Engagement Program (IM-REP), Pittsburgh
RECRUITING
MATClinics, Dundalk
RECRUITING
Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, Baltimore
RECRUITING
Wells House, Hagerstown
RECRUITING
WVU Crisis Support & Recovery Center, Martinsburg
RECRUITING
WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT), Morgantown
NOT_YET_RECRUITING
Central City Concern (CCC), Portland
NOT_YET_RECRUITING
Recovery Works Northwest (RWNW), Portland
NOT_YET_RECRUITING
OHSU Harm Reduction Bridges to Care (HRBR), Portland
NOT_YET_RECRUITING
OHSU Internal Medicine Clinic (IMC), Portland
National Institute on Drug Abuse (NIDA)
NIH
Erin Winstanley
OTHER