Clinical trial NCT06837662: The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Official title: Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Dependence
Substance Abuse Disorders
Complex Medical Patients
Primary Care Patients With Chronic Conditions
Keywords: opioid use disorder
medications for opioid use disorder
recovery capital
collaborative care model
addiction treatment
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Central City Concern
First posted: 2025-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "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.
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: Inclusion Criteria:

* Eligibility/Inclusion Criteria. For Aim 3, criteria we seek to recruit include:
* 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 14 days (+/- 3 business days) 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

Exclusion Criteria:

* 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 with severe and persistent mental illness (e.g., diagnosis of psychosis, schizophrenia, or bipolar) 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.

Primary outcomes:
measure: Retention on MOUD
timeFrame: assessed at 2 month, 3 months, and 6 month post enrollment
Secondary outcomes:
measure: Engagement with care team
timeFrame: Assessed at 3-month follow-up post enrollment
measure: Change in recovery capital instrument (BARC-10)
timeFrame: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
measure: Change in patient reported trust in care team
timeFrame: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
Other outcomes:
measure: Change in opioid use based on self-report
timeFrame: Baseline, 2, 3, and 6 months
measure: Change in other drug use (alcohol, methamphetamine) based on self-report
timeFrame: Baseline, 2, 3, and 6 months
measure: Hospitalization and ED visits for substance use related problem
timeFrame: Baseline, 2, 3, and 6 months
Locations:
city: Portland
country: United States
facility: Central City Concern
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Brian Chan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: