NCT06837662

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

Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a pilot randomized controlled trial (N=70) comparing the refined team-based collaborative care model ("MOUD Plus") to treatment as usual. The hypothesis is that this team-based intervention, called "MOUD-Plus", consisting of prescribers along with integrated substance use counselor, and referral to community based peer recovery support, can improve care engagement and retention on MOUD by increasing engagement, building trust, and offering patient directed therapeutic and peer-enhanced support for their treatment on MOUD. Main existing components of MOUD: ("Treatment as Usual") 1. Scheduled or Walk in clinic M-F 8-5 pm 2. Visits with buprenorphine waivered prescriber 3. Prescribers are trained to initiate and continue treatment same day ("low threshold" prescribing) 4. Connection to usual primary care services 5. On-site lab, pharmacy, and screening for HIV, hep C with referral to treatment "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. Outcomes: 1. Retention on medication for opioid use disorder (MOUD) at 2, 3-months (primary), and 6-months 2. Engagement with care teams at 2, 3, and 6-months (secondary, mechanism of action) 3. Change in trust in care team, and recovery capital at 2 months, 3, and 6-months (secondary outcomes) 4. Assess feasibility, acceptability, and potential scalability of the program using the RE-AIM-QuEST framework

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-02-20
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States