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

PHASE4RecruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

May 28, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

October 31, 2026

Conditions
Opioid Use DisorderChronic Pain
Interventions
DRUG

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."

BEHAVIORAL

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."

BEHAVIORAL

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."

DRUG

Standard Buprenorphine Dosing Condition

Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.

Trial Locations (13)

15068

RECRUITING

UPMC St. Margaret Family Health Center, New Kensington

15132

RECRUITING

UPMC Latterman Family Health Center, McKeesport

15213

RECRUITING

UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC), Pittsburgh

15219

RECRUITING

UPMC Internal Medicine Recovery Engagement Program (IM-REP), Pittsburgh

21222

RECRUITING

MATClinics, Dundalk

21223

RECRUITING

Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, Baltimore

21740

RECRUITING

Wells House, Hagerstown

25401

RECRUITING

WVU Crisis Support & Recovery Center, Martinsburg

26505

RECRUITING

WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT), Morgantown

97209

NOT_YET_RECRUITING

Central City Concern (CCC), Portland

97233

NOT_YET_RECRUITING

Recovery Works Northwest (RWNW), Portland

97239

NOT_YET_RECRUITING

OHSU Harm Reduction Bridges to Care (HRBR), Portland

NOT_YET_RECRUITING

OHSU Internal Medicine Clinic (IMC), Portland

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Erin Winstanley

OTHER