The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care

Summary

The goal of this pilot clinical trial is to learn if a community informed designed program of addiction counseling with coordinated community peer navigator for people with Opioid Use Disorder (OUD) and other medical conditions can improve engagement in primary care and retention on buprenorphine.

The main questions it aims to answer are:

* Does the addition of a counseling and peer referral interventions in addition to usual primary care with low-threshold buprenorphine increase retention on medications for opioid use disorder?
* Does the addition of counseling and peer referral intervention in addition to usual primary care with low-threshold buprenorphine increase engagement in primary care?

Researchers will compare the MOUD "Plus" intervention compared to primary care treatment as usual low-threshold buprenorphine prescribing practice to see if MOUD "Plus" improves retention and engagement.

Participants will upon screening and enrollment:

* Meet with prescribers who will determine dose of buprenorphine and assess other medical issues as per treatment as usual with visits every 2-4 weeks
* Meet with the integrated addictions counselor to develop rapport and support around clinic engagement, brief counseling intervention, and coordination of care in support of their MOUD
* Be referred to a community based peer who meets with participants outside the clinic for support and advocacy for patient directed recovery goals
* Meet with the research coordinator at 2, 3, and 6 months to complete follow-up surveys about their care and experiences

Conditions

• Opioid Dependence
• Substance Abuse Disorders
• Complex Medical Patients
• Primary Care Patients With Chronic Conditions

Interventions

BEHAVIORAL

MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer)

In addition to treatment as usual (clinic visits for primary care and MOUD), patients will meet with clinic based addictions counselor who provides 1) rapport building ; 2) brief counseling interventions (e.g. motivational interviewing, change talk/solutions based therapy, harm reduction counseling); 3) referral to community resources. Patients will also be referred to community based peer recovery services who are credentialed and trained to "meet the person where they are" in the community and provide advocacy and support for client directed goals.

BEHAVIORAL

Treatment As Usual (primary care with low threshold MOUD prescribing)

Treatment as usual arm consists of primary care clinical appointments with prescribers who treat medical issues and are trained to diagnosis and treat OUD using low threshold prescribing approaches.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Central City Concern

  collaborator UNKNOWN

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Brian Chan, MD MPH · Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-24

Primary Completion

2026-08-01

Completion

2026-12-01

Countries

• United States

Study Locations