Opioid DependenceMOUD+NCT06837662
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
A study testing MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer) and Treatment As Usual (primary care with low threshold MOUD prescribing) in people with Opioid Dependence and Substance Abuse Disorders, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Substance Abuse Disorders, Complex Medical Patients
- What is being tested?
- MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer) and Treatment As Usual (primary care with low threshold MOUD prescribing)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study
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:
Read more
- 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
Read the 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")
- Scheduled or Walk in clinic M-F 8-5 pm
- Visits with buprenorphine waivered prescriber
- Prescribers are trained to initiate and continue treatment same day ("low threshold" prescribing)
- Connection to usual primary care services
- On-site lab, pharmacy, and screening for HIV, hep C with referral to treatment
"MOUD Plus": New Components to support OUD and medical complexity
- 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.
- Referral and coordination with outside peer organizations that work with the program to assist medically complex clients to support self-efficacy and treatment goals.
- Enhanced care coordination and panel management to address continuity of care and medication management for those enrolled.
Outcomes:
- Retention on medication for opioid use disorder (MOUD) at 2, 3-months (primary), and 6-months
- Engagement with care teams at 2, 3, and 6-months (secondary, mechanism of action)
- Change in trust in care team, and recovery capital at 2 months, 3, and 6-months (secondary outcomes)
- 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
- Being tested
- MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer), Treatment As Usual (primary care with low threshold MOUD prescribing)
- Keywords
- opioid use disorder, medications for opioid use disorder, recovery capital, collaborative care model, addiction treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer)Behavioural
Also called collaborative care, integrated behavioral health, MOUD Plus
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)Behavioural
Also called usual care, treatment as usual, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Treatment As Usual (primary care with low threshold MOUD prescribing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed at 2 month, 3 months, and 6 month post enrollment
Secondary outcomes (3)
Engagement with care team
Engagement with care team is defined by number of unique contacts (in person visits, telephone visits, telephone outreach, peer engagements) the participant has with each arm during the course of the study
Measured: Assessed at 3-month follow-up post enrollment
Change in recovery capital instrument (BARC-10)
We assess recovery capital using the brief assessment of recovery capital (BARC-10) which ranges from minimum of 10 to maximum of 60.
Measured: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
Change in patient reported trust in care team
We assess trust in care team using a modified version Wake Forest Physician Trust scale which ranges from minimum of 10 to maximum of 50.
Measured: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start24 Mar 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Central City Concern
- Responsible party
- Principal investigator, Brian L Chan, Oregon Health and Science University
- Investigators
- Brian Chan, MD MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837662
- Sponsor's protocol ID
- STUDY00024006
- Other IDs
- 5K23DA053390
- Acronym
- MOUD+
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, analysis, and publication, a de-identified IPD that underlie results in a publication will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study
- ClinicalTrials.gov ID
- NCT06837662
- Acronym / sponsor ID
- MOUD+ / STUDY00024006
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Central City Concern
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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")
- Scheduled or Walk in clinic M-F 8-5 pm
- Visits with buprenorphine waivered prescriber
- Prescribers are trained to initiate and continue treatment same day ("low threshold" prescribing)
- Connection to usual primary care services
- On-site lab, pharmacy, and screening for HIV, hep C with referral to treatment
"MOUD Plus": New Components to support OUD and medical complexity
- 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.
- Referral and coordination with outside peer organizations that work with the program to assist medically complex clients to support self-efficacy and treatment goals.
- Enhanced care coordination and panel management to address continuity of care and medication management for those enrolled.
Outcomes:
- Retention on medication for opioid use disorder (MOUD) at 2, 3-months (primary), and 6-months
- Engagement with care teams at 2, 3, and 6-months (secondary, mechanism of action)
- Change in trust in care team, and recovery capital at 2 months, 3, and 6-months (secondary outcomes)
- Assess feasibility, acceptability, and potential scalability of the program using the RE-AIM-QuEST framework
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MOUD Plus Arm (treatment as usual + integrated counseling and peer referral) | Experimental | Behavioral: MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer)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 |
| Treatment as usual Arm (low threshold MOUD prescribing in primary care) | Active comparator | Behavioral: Treatment As Usual (primary care with low threshold MOUD prescribing)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Medical complexity (e.g. self-reported or verified in patient's electronic health record)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer)Also: collaborative care, integrated behavioral health, MOUD PlusIn 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. | Behavioural | MOUD Plus Arm (treatment as usual + integrated counseling and peer referral) |
| Treatment As Usual (primary care with low threshold MOUD prescribing)Also: usual care, treatment as usual, low-threshold MOUD prescribingTreatment 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. | Behavioural | Treatment as usual Arm (low threshold MOUD prescribing in primary care) |
Primary outcome
Retention on MOUD
Time frame: assessed at 2 month, 3 months, and 6 month post enrollment
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.
3 secondary outcomes
Engagement with care team
Time frame: Assessed at 3-month follow-up post enrollment
Change in recovery capital instrument (BARC-10)
Time frame: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
Change in patient reported trust in care team
Time frame: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. After completion of the study, analysis, and publication, a de-identified IPD that underlie results in a publication will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Chan, MD MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer) and Treatment As Usual (primary care with low threshold MOUD prescribing) in people with Opioid Dependence and Substance Abuse Disorders, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention on MOUD (time frame: assessed at 2 month, 3 months, and 6 month post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.