Counseling and Peer Support for Opioid Use Disorder

(MOUD+ Trial)

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Buprenorphine

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding counseling and peer support to usual care can help people with Opioid Use Disorder (OUD) adhere to their medication and engage more with primary care. Usual care includes medication for OUD, such as buprenorphine, while the new approach, called the MOUD Plus Pilot, provides additional support from counselors and community peers. The trial targets individuals with an OUD-related diagnosis who have recently used opioids like fentanyl or heroin and wish to participate in counseling or peer services. Participants will meet with prescribers, counselors, and peers to support their recovery goals. As an unphased trial, this study offers a unique opportunity to explore new supportive approaches for OUD recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding counseling and peer support to your existing treatment with buprenorphine for opioid use disorder.

What prior data suggests that this program of counseling and peer support is safe for people with Opioid Use Disorder?

Research has shown that the MOUD Plus program, which combines counseling and peer support with standard care, is well-received. A previous study found that participants using MOUD reduced substance use and improved health after six months, indicating the treatment's safety for individuals with opioid use disorder (OUD).

Further research supports the role of peer recovery support in helping individuals remain engaged in their OUD treatment. Staying in treatment is crucial, as it is linked to better health outcomes. These findings suggest that the MOUD Plus program is safe and could benefit those seeking to improve their health and maintain engagement in care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MOUD Plus because it enhances standard opioid use disorder treatments by adding integrated counseling and peer support. Unlike the usual approach that involves low-threshold medication-assisted treatment in a primary care setting, MOUD Plus provides coordinated warm handoffs to counseling services and community-based peer support. This comprehensive care strategy aims to improve patient outcomes by addressing both the medical and psychosocial aspects of recovery, potentially offering a more holistic and supportive path to overcoming opioid dependency.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that adding counseling and peer support to standard treatment for opioid use disorder (OUD) can be beneficial. In this trial, participants in the MOUD Plus Arm will receive treatment as usual, which includes medication-assisted treatment like MOUD, along with integrated counseling and peer referral. Studies have found that medication-assisted treatment can reduce drug use and improve both physical and mental health over six months. Specifically, individuals who continued with MOUD after leaving a treatment center had fewer emergency room visits, spent fewer days in the hospital, and experienced fewer overdoses within 90 days. The MOUD Plus Arm aims to help people stay on MOUD and engage more with primary care by combining medication with counseling and peer support. This approach seeks to help individuals adhere to their treatment and achieve better overall health. ^{1 2 5 6 7}

Who Is on the Research Team?

Brian Chan, MD MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals with Opioid Use Disorder (OUD) who also have other medical conditions. They should be seeking care in primary care settings and are willing to engage in a program that includes medication, counseling, and peer support.

Inclusion Criteria

Who meet at least one of the following criteria:

Medical complexity (e.g. self-reported or verified in patient's electronic health record)

I have been diagnosed with or have used opioids like fentanyl or heroin in the last 30 days.

Exclusion Criteria

Patients who participated in Aim 2 would not be eligible for Aim 3

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MOUD Plus intervention, including counseling and peer support, alongside usual primary care with buprenorphine

6 months

Visits every 2-4 weeks with prescribers, plus additional meetings with counselors and peers

Follow-up

Participants are monitored for retention on MOUD and engagement with care teams, with assessments at 2, 3, and 6 months

6 months

Follow-up surveys at 2, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• MOUD Plus Pilot

Trial Overview The study tests if adding coordinated counseling and community-based peer support to usual primary care improves patient retention on buprenorphine (a medication for OUD) and engagement in primary care compared to standard treatment.

How Is the Trial Designed?

Group I: MOUD Plus Arm (treatment as usual + integrated counseling and peer referral) Experimental Treatment 1 Intervention

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

Group II: Treatment as usual Arm (low threshold MOUD prescribing in primary care) Active Control 1 Intervention

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 Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Central City Concern

Collaborator

Trials

2

Recruited

270+

Published Research Related to This Trial

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

A qualitative study involving 26 patients receiving methadone treatment found that a peer recovery specialist-delivered behavioral activation intervention (Peer Activate) was perceived as acceptable and feasible, particularly due to its flexibility and the supportive qualities of the peer specialists.

Participants highlighted the importance of connecting with the intervention content and building skills, while also noting stigma related to substance use and methadone treatment as barriers to engagement, suggesting that addressing these issues could enhance treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You rise up and then you start pulling people up with you": Patient experiences with a peer-delivered behavioral activation intervention to support methadone treatment. Kleinman, MB., Hines, AC., Anvari, MS., et al.[2023]

The tailored telephone intervention delivered by peers (TTIP-PRO) was well-received by participants, with all eight patients finding it 'very helpful' and showing a significant increase in their knowledge about opioid overdoses, from 69.9% to 93.6% correct responses after the intervention.

While interest in starting medication-assisted treatment (MAT) increased from 8.1 to 9.5 on a 10-point scale, this change was not statistically significant, indicating that further development and testing of TTIP-PRO is needed to effectively encourage MAT enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Winhusen, T., Theobald, J., Lewis, D., et al.[2022]

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

In a study of 2332 Medicaid adults with opioid use disorder, initiating medication for opioid use disorder (MOUD) during inpatient care significantly reduced the likelihood of patients leaving against medical advice and decreased 30-day hospital readmissions.

Patients who adhered to MOUD after discharge experienced notable reductions in emergency department visits, inpatient days, and opioid overdoses within 90 days, highlighting the effectiveness of inpatient MOUD induction in improving long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Inpatient Induction on Medications for Opioid Use Disorder and Postdischarge Medications for Opioid Use Disorder Adherence, Overdose, and Service Use. Noam, KR., Schmutte, TJ., Pirard, S., et al.[2023]

Peer support models have been effective in helping individuals with opioid use disorder (OUD) start treatment and reduce relapse rates, highlighting their potential in addressing the opioid crisis.

Integrating peer coaches into online interventions within community settings shows promise for engaging people with OUD, suggesting a novel approach to enhance treatment accessibility and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Peer Coaches in Digital Interventions for MOUD Initiation and Maintenance. Garett, R., Young, SD.[2023]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

Patients receiving methadone treatment reported experiencing various forms of stigma related to substance use and medication, which significantly hindered their retention in opioid use disorder treatment programs.

Peer recovery specialists (PRSs), who share similar experiences with substance use and recovery, have the potential to reduce stigma and improve retention in medication for opioid use disorder by leveraging their unique perspectives and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. Anvari, MS., Kleinman, MB., Massey, EC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8722086/

Outcomes from the medication assisted treatment pilot ... This study shows decreased substance use, improved physical and mental health, and reduced symptoms after 6 months of MOUD.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827185

Smartphone App–Based Contingency Management and ... Although MOUD is often effective at reducing personal and societal harms, some patients still experience difficulties with continued opioid use ...

3. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00424-4

Outcomes from the medication assisted treatment pilot ... This study shows decreased substance use, improved physical and mental health, and reduced symptoms after 6 months of MOUD.

4. withpower.com withpower.com/trial/phase-complex-medical-patients-1-2025-d397a

Counseling and Peer Support for Opioid Use Disorder ... Patients who adhered to MOUD after discharge experienced notable reductions in emergency department visits, inpatient days, and opioid overdoses within 90 days ...

5. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/moud-study.html

Medications for Opioid Use Disorder (MOUD) Study The MOUD study examined patient outcomes from several opioid use disorder (OUD) treatments.

6. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2024.2392870

Full article: Virtual reality-based Mindfulness-Oriented ... Participants reported high usability and acceptability of MORE-VR, which had an excellent safety profile. Illicit opioid use decreased ...

7. translationalsciencebenefits.wustl.edu translationalsciencebenefits.wustl.edu/case-study/the-moud-plus-study-collaborating-with-recovery-peers-to-support-opioid-use-disorder-treatment-retention-in-primary-care/

The MOUD “PLUS” Study: Collaborating with Recovery ... The MOUD PLUS study aims to improve care engagement and retention for people with OUD seen in primary care. The study pilots implementation of ...