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

NCT06837662 | Recruiting

• 2 other identifiers: STUDY000240065K23DA053390
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

opioid use disorder; medications for opioid use disorder; recovery capital; collaborative care model; addiction treatment

Outcome Measures

Primary Outcomes (1)

• Retention on MOUD

  Retention is defined as a composite measure assessed at follow-up on whether they report being prescribed and taking MOUD, and how days since the last follow-up they have been on MOUD, confirmed by chart review.

  assessed at 2 month, 3 months, and 6 month post enrollment

Secondary Outcomes (3)

• Engagement with care team

  Assessed at 3-month follow-up post enrollment

• Change in recovery capital instrument (BARC-10)

  Change between baseline and assessed at 2-month, 3-month, and 6-month follow up

• Change in patient reported trust in care team

  Change between baseline and assessed at 2-month, 3-month, and 6-month follow up

Other Outcomes (3)

• Change in opioid use based on self-report

  Baseline, 2, 3, and 6 months

• Change in other drug use (alcohol, methamphetamine) based on self-report

  Baseline, 2, 3, and 6 months

• Hospitalization and ED visits for substance use related problem

  Baseline, 2, 3, and 6 months

Study Arms (2)

MOUD Plus Arm (treatment as usual + integrated counseling and peer referral)

EXPERIMENTAL

Treatment as usual (prescriber trained in low threshold MOUD prescribing practices) plus coordinated warm-handoffs with integrated counseling services and coordinated referral to community based peer services

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

Treatment as usual Arm (low threshold MOUD prescribing in primary care)

ACTIVE COMPARATOR

Current treatment as usual consists of scheduled appointments with prescribers who are trained in low-threshold MOUD prescribing practices and who are part of a patient centered medical home model of care

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

Interventions

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

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.

Also known as: usual care, treatment as usual, low-threshold MOUD prescribing

Treatment as usual Arm (low threshold MOUD prescribing in primary care)

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

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.

Also known as: collaborative care, integrated behavioral health, MOUD Plus

MOUD Plus Arm (treatment as usual + integrated counseling and peer referral)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient participants 18 years and older
• Have an OUD-related diagnosis (e.g. Opioid Use Disorder in remission, Opioid Dependence, Opioid Abuse, Substance Use Disorder - opioids, etc.), or have used fentanyl or heroin over the past 30 days
• Who meet at least one of the following criteria:
• Present to primary care at Central City Concern (CCC) within 8 weeks of starting or re-starting a treatment episode (defined as starting MOUD after not having received prescribed MOUD in an outpatient setting for OUD in the prior 30 days).
• Who present to primary care at CCC and are not seeking treatment with MOUD and have not engaged in counseling services (e.g. harm reduction counseling) in the prior 30 days
• Have been receiving MOUD in prior 30 days but had a return to use (used fentanyl or heroin) within the past 30 days
• Medical complexity (e.g. self-reported or verified in patient's electronic health record)
• Have access to phone and/or computer for follow-up activities
• Desire to engage in counseling and/or peer services

You may not qualify if:

• Patient participants who present for addiction treatment but are ineligible to receive on-going services at Central City (i.e. they have existing primary care at another location, or are currently receiving opioid use disorder treatment at another clinic, such as methadone clinic) may not participate in the study.
• Patient participants who are not able to verbally consent may not participate in the study.
• Patients who do not have addiction to opioids may not participate in the study.
• Patients who participated in Aim 2 would not be eligible for Aim 3
• Patients who lack stable phone access may not participate in the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Central City Concern: collaborator

Study Sites (1)

Central City Concern

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics; Primary Health Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Brian Chan, MD MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

503-346-3043; cheslocm@ohsu.edu

Principal Investigator

CONTACT

503-494-2010

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care providers may be masked to treatment assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: "MOUD Plus": New Components to support OUD and medical complexity 1. Engagement with an Integrated Substance Use Disorders (SUDS) Counselor for medical complexity to aid in rapport building, brief counseling interventions (e.g., motivational interviewing, harm reduction counseling), and care coordination. 2. Referral and coordination with outside peer organizations that work with the program to assist medically complex clients to support self-efficacy and treatment goals. 3. Enhanced care coordination and panel management to address continuity of care and medication management for those enrolled.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting after publication of the main results, and for 5 years after.
• Access Criteria: Anyone who makes a reasonable request to the primary investigator via email with rationale and data analysis plan/question

Locations

US (1)