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

Last updated: August 1, 2024
Sponsor: Jessica Merlin
Overall Status: Active - Recruiting

Phase

4

Condition

Opioid Use Disorder

Chronic Pain

Pain

Treatment

Patient-Oriented Dosing (POD)

Standard Buprenorphine Dosing Condition

Pain Self-Management (PSM)

Clinical Study ID

NCT06367387
STUDY23080191
RM1DA055311
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following 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 (3months)

  • New treatment episode is defined as not having received prescribedbuprenorphine treatment in an outpatient setting for OUD in the prior 30 days (1 month)
  1. 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 newepisode of care

  2. Have high impact chronic pain (Grade 3), based on the Graded Chronic PainScale-Revised (GCPS-R)

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  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 orhave pending legal action that could prevent participation in study activities

  4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combinationproduct

  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 causedserious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylacticshock

Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.

Study Design

Total Participants: 460
Treatment Group(s): 4
Primary Treatment: Patient-Oriented Dosing (POD)
Phase: 4
Study Start date:
May 13, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

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

    Baltimore, Maryland 21223
    United States

    Active - Recruiting

  • Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Outpatient Addiction Treatment Services (OATS)

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Wells House

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Central City Concern (CCC)

    Portland, Oregon 97209
    United States

    Site Not Available

  • OHSU Harm Reduction Bridges to Care (HRBR)

    Portland, Oregon 97239
    United States

    Site Not Available

  • OHSU Internal Medicine Clinic (IMC)

    Portland, Oregon 97239
    United States

    Site Not Available

  • Recovery Works Northwest (RWNW)

    Portland, Oregon 97233
    United States

    Site Not Available

  • UPMC Latterman Family Health Center

    McKeesport, Pennsylvania 15132
    United States

    Active - Recruiting

  • UPMC St. Margaret Family Health Center

    New Kensington, Pennsylvania 15068
    United States

    Active - Recruiting

  • UPMC Internal Medicine Recovery Engagement Program (IM-REP)

    Pittsburgh, Pennsylvania 15219
    United States

    Active - Recruiting

  • WVU Crisis Support & Recovery Center

    Martinsburg, West Virginia 25401
    United States

    Active - Recruiting

  • WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.