Recruiting

MOUD "Plus"

Sponsor:

Oregon Health and Science University

Code:

NCT06837662

Conditions

Opioid Dependence

Substance Abuse Disorders

Complex Medical Patients

Primary Care Patients With Chronic Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Opioid Dependence

Substance Abuse Disorders

Complex Medical Patients

Primary Care Patients With Chronic Conditions

Study ID

NCT06837662

Start date

Mar 24, 2025

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

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 who participated in Aim 2 would not be eligible for Aim 3
  • Patients who lack stable phone access may not participate in the study.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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.

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.

Primary outcome measure

  • Retention on MOUD [ Time Frame: assessed at 2 month, 3 months, and 6 month post enrollment ]

Central Contacts and Locations

Central contacts

Study Coordinator

503-346-3043cheslocm@ohsu.edu

Principal Investigator

503-494-2010

Locations

Central City Concern

Recruiting

Portland, Oregon, United States, 97239

Contacts

Research Coordinator

503-346-3043cheslocm@ohsu.edu

Principal Investigator:

Brian Chan, MD MPH

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-02-25.