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

70 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment MOUD Plus Pilot for opioid use disorder?

Research shows that peer recovery support services, like those in the MOUD Plus Pilot, can help people stay engaged in treatment for opioid use disorder. Studies have found that peer interventions can increase interest in medication-assisted treatment and improve knowledge about opioid overdose prevention. ^{1 2 3 4 5}

Is counseling and peer support for opioid use disorder safe for humans?

The research does not provide specific safety data for counseling and peer support for opioid use disorder, but these interventions are generally considered safe as they focus on support and engagement rather than medical procedures or medications. ^{1 2 4 6 7}

How is the MOUD Plus Pilot treatment different from other treatments for opioid use disorder?

The MOUD Plus Pilot treatment is unique because it combines medication for opioid use disorder (MOUD) with counseling and peer support, which helps address both the medical and social aspects of recovery. This approach is particularly innovative as it involves peer recovery specialists who have personal experience with substance use, making them effective in reducing stigma and encouraging treatment retention. ^{2 6 8 9 10}

What is the purpose of this trial?

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

Research Team

Brian Chan, MD MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

I am able to give verbal consent.

Patients who do not have addiction to opioids may not participate in the study

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

2. Ireland 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. [2022]

3. Netherlands 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. [2023]

4. Netherlands 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). [2022]

6. United States 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. [2023]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Holyoke Early Access to Recovery and Treatment (HEART): A case study of a court-based intervention to reduce opioid overdose. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Role of Peer Coaches in Digital Interventions for MOUD Initiation and Maintenance. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Factors associated with counselling adherence in opioid treatment programs. [2023]