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

Description

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.

Conditions

Opioid Use Disorder, Chronic Pain

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

Outpatient Addiction Treatment Services (OATS), Baltimore, Maryland, United States, 21201

Baltimore

Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, Baltimore, Maryland, United States, 21223

Baltimore

Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, 21224

Hagerstown

Wells House, Hagerstown, Maryland, United States, 21740

Portland

Central City Concern (CCC), Portland, Oregon, United States, 97209

Portland

Recovery Works Northwest (RWNW), Portland, Oregon, United States, 97233

Portland

OHSU Harm Reduction Bridges to Care (HRBR), Portland, Oregon, United States, 97239

Portland

OHSU Internal Medicine Clinic (IMC), Portland, Oregon, United States, 97239

McKeesport

UPMC Latterman Family Health Center, McKeesport, Pennsylvania, United States, 15132

New Kensington

UPMC St. Margaret Family Health Center, New Kensington, Pennsylvania, United States, 15068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adults at least 18 years old from participating clinics
  • 2. Ability to speak, read, and understand English
  • 3. Capable of providing informed consent
  • 4. Access to phone and/or internet
  • 5. Documented diagnosis of Opioid Use Disorder (OUD)
  • 6. Within \<180 days (6 months) of a new treatment episode, ideally within 90 days (3 months)
  • * New treatment episode is defined as not having received prescribed buprenorphine treatment in an outpatient setting for OUD in the prior 30 days (1 month)
  • 7. 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
  • 8. Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)
  • 1. Under 18 years of age
  • 2. Have cancer-related pain
  • 3. Are currently in jail, prison, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
  • 4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
  • 5. Currently prescribed an injectable formulation of buprenorphine
  • 6. Pregnancy or intention to become pregnant within 4 months of enrollment
  • 7. Currently prescribed naltrexone
  • 8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jessica Merlin,

Jessica S Merlin, MD, PhD, MBA, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-12