Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
United States
Maryland
Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center
RECRUITING
Baltimore
MATClinics
RECRUITING
Dundalk
Wells House
RECRUITING
Hagerstown
Oregon
Central City Concern (CCC)
NOT_YET_RECRUITING
Portland
OHSU Harm Reduction Bridges to Care (HRBR)
NOT_YET_RECRUITING
Portland
OHSU Internal Medicine Clinic (IMC)
NOT_YET_RECRUITING
Portland
Recovery Works Northwest (RWNW)
NOT_YET_RECRUITING
Portland
Pennsylvania
UPMC Latterman Family Health Center
RECRUITING
Mckeesport
UPMC St. Margaret Family Health Center
RECRUITING
New Kensington
UPMC Internal Medicine Recovery Engagement Program (IM-REP)
RECRUITING
Pittsburgh
UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC)
RECRUITING
Pittsburgh
West Virginia
WVU Crisis Support & Recovery Center
RECRUITING
Martinsburg
WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)
RECRUITING
Morgantown
Contact Information
Primary
Melessa Salay, MPH
TREETOP@pitt.edu
412-648-7896
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 268
Treatments
Active_comparator: Usual Care + Standard Buprenorphine Dosing
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.~Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Experimental: Usual Care + Patient-Oriented Dosing (POD)
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.~Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Experimental: Pain Self-Management (PSM) + Standard Buprenorphine Dosing
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions.~Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Experimental: Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions.~Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Erin Winstanley

This content was sourced from clinicaltrials.gov