PRSS + TAU for Opioid Use Disorder

Not currently recruiting at 1 trial location

Overseen By Kevin R. Wenzel, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Potomac Health Foundations

Must be taking: MOUD

Disqualifiers: Formalized PRSS, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 38

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding peer recovery support services (PRSS) helps individuals adhere to their medication for opioid use disorder (MOUD) more effectively than usual treatment alone. PRSS provides support from individuals with personal experience in substance use, offering coaching and guidance. The trial will compare two groups: one receiving usual care and another receiving usual care plus PRSS. Ideal candidates for this trial live in recovery residences, are already taking MOUD, and are not currently receiving formal peer support. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery support strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on medications for opioid use disorder (MOUD) like methadone, buprenorphine, or naltrexone.

What prior data suggests that Peer Recovery Support Services (PRSS) are safe for individuals with opioid use disorder?

Research shows that Peer Recovery Support Services (PRSS) can be a safe and helpful option for people with opioid use disorder. Studies have found that those who receive peer support often find it beneficial for their recovery. For instance, one study found that PRSS can help more people start and continue using medications for opioid use disorder (MOUD).

The evidence suggests that PRSS is generally well-received. People in various settings have reported positive experiences with peer support, often feeling understood and supported by someone who has faced similar challenges. While some gaps remain in the research, the available data does not show any serious safety concerns related to PRSS.

Overall, PRSS is seen as a promising way to help improve treatment retention and outcomes for those dealing with opioid addiction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Peer Recovery Support Services (PRSS) + Treatment as Usual (TAU) for opioid use disorder because it introduces a unique support system that differs from traditional medication or therapy-based treatments. Unlike standard treatments that primarily focus on medication-assisted therapy like methadone or buprenorphine, PRSS leverages peer support to enhance recovery. This method aims to improve retention in medication programs by building community and offering lived-experience insights, which can provide a more relatable and motivational recovery journey. By integrating peer support with usual care, this approach could lead to better long-term recovery outcomes and increased adherence to medication plans.

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

Research has shown that Peer Recovery Support Services (PRSS) can assist individuals with substance use problems, such as opioid use disorder (OUD). Some studies have found that PRSS, which involves support from those who have faced similar challenges, helps individuals remain engaged in treatment. Early findings suggest that PRSS might encourage adherence to medications for opioid use disorder (MOUD), which is crucial for reducing the risk of relapse and overdose. However, more research is needed to confirm PRSS's effectiveness in supporting MOUD adherence. In this trial, one group will receive PRSS combined with Treatment as Usual (TAU), while another group will receive TAU alone. Combining PRSS with regular treatment aims to leverage both structured support and shared personal experiences to improve outcomes for those with OUD. ^{1 2 3 6 7}

Who Is on the Research Team?

Marc Fishman, MD

Principal Investigator

Mountain Manor Treatment Center - Maryland Treatment Centers

Kevin R. Wenzel, Ph.D.

Principal Investigator

Mountain Manor Treatment Center - Maryland Treatment Centers

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Opioid Use Disorder (OUD) who live in a Recovery Residence (RR) and are on Medications for Opioid Use Disorder (MOUD). They must speak English, be able to consent, and not already receiving formal Peer Recovery Support Services outside of the study.

Inclusion Criteria

English speaking

Willing and able to provide informed consent

I have been diagnosed with opioid use disorder.

Exclusion Criteria

Currently receiving formalized PRSS outside of the study (not applicable to peer support typical of sponsorship in 12-step mutual support programs or informal support through RRs)

Timeline for a Trial Participant

Preparation

Preparation for the intervention including building a network of recovery residences, recruiting and training peer support specialists, conducting focus groups and interviews, and developing PRSS approaches to promote MOUD retention.

Not specified

Intervention

Pilot test the PRSS intervention by randomizing 50 individuals on MOUD to either a 24-week course of the PRSS intervention added to usual services, or usual services without the PRSS intervention.

24 weeks

Follow-ups at weeks 2, 4, 8, 12, 16, 20, 24

Post-Intervention

Gather additional input from former participants and RR staff post-intervention to further refine the intervention and inform trial design and data collection procedures for the next-step R01 application.

Not specified

Follow-up

Participants are monitored for MOUD retention and other outcomes at weeks 36 and 52.

28 weeks

Follow-ups at weeks 36 and 52

What Are the Treatments Tested in This Trial?

Interventions

• Peer Recovery Support Services (PRSS) + TAU
• Treatment as Usual (TAU)

Trial Overview The study tests if adding Peer Recovery Support Services (PRSS), like recovery coaching, to usual treatment helps people stay on MOUD longer. Participants will either receive PRSS plus standard care or just standard care. The impact of PRSS on staying in treatment will be evaluated.

How Is the Trial Designed?

Group I: Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU Experimental Treatment 1 Intervention

Arm 2: Peer Recovery Support Services (PRSS) Intervention: The experimental group for this study that involves the implementation of the PRSS intervention. This study will test the preliminary efficacy of the PRSS intervention on Medications for Opioid Use Disorder (MOUD) retention by evenly randomizing N=50 individuals on MOUD living in recovery residences (RRs) to either a 24-week course of the experimental PRSS intervention layered on top of treatment as usual services (TAU+PRSS) vs. an active comparator composed of treatment as usual services without the PRSS intervention (i.e., TAU-alone). Follow ups will be conducted at weeks 2, 4, 8, 12, 16, 20, 24 (end of intervention), 36, and 52 to collect data on the primary outcome of MOUD retention and other outcomes.

Group II: Arm 1 Title: Treatment as Usual (TAU) Active Control 1 Intervention

Arm 1: Treatment as Usual (TAU): The treatment and/or other services received as part of usual care while living in a recovery residence. This arm serves as the active comparator group for the study.

Peer Recovery Support Services (PRSS) + TAU is already approved in United States for the following indications:

Approved in United States as Peer Recovery Support Services for:

• Substance Use Disorder (SUD) support
• Medications for Opioid Use Disorder (MOUD) retention

Who Is Running the Clinical Trial?

Potomac Health Foundations

Lead Sponsor

Trials

7

Recruited

490+

National Institute of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Peer recovery support services (PRSS) have been integrated into the recovery process for opioid use disorder (OUD), but their effectiveness on clinical outcomes remains unclear, as only 12 out of 123 studies met the inclusion criteria for review.

Most studies reported on PRSS engagement and medication for OUD (MOUD) initiation, but findings were inconsistent and varied due to the lack of standardized PRSS interventions and methodological limitations, indicating a need for further research before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. Gormley, MA., Pericot-Valverde, I., Diaz, L., 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]

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 integration of recovery coaches in outpatient substance use disorder (SUD) treatment led to a 44% reduction in hospitalizations and a 9% decrease in emergency department visits among 1171 patients over six months.

Patients who initiated buprenorphine treatment and had contact with recovery coaches showed nearly double the odds of engaging in treatment and a 32% increase in opioid abstinence, highlighting the effectiveness of recovery coaches in supporting SUD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery coaches in general medical settings: Changes in utilization, treatment engagement, and opioid use. Magidson, JF., Regan, S., Powell, E., et al.[2021]

A study involving 32 participants indicated that a peer recovery specialist-delivered behavioral activation intervention could be both feasible and acceptable for supporting retention in methadone treatment for opioid use disorder.

Participants highlighted the potential of this intervention to address challenges related to unstructured time in treatment, suggesting that peer support could enhance engagement and outcomes for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. Kleinman, MB., Anvari, MS., Bradley, VD., 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]

Emergency department-based peer support programs are effective in connecting individuals with opioid use disorder (OUD) to medication and recovery services, showing promise in addressing the opioid crisis.

The integration of peer support varies across programs, affecting how peers are alerted to potential patients and how they engage with them, highlighting the need for consistent reporting on these methods in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. McGuire, AB., Powell, KG., Treitler, PC., et al.[2021]

In a pilot study involving 80 adults with recent non-fatal opioid overdoses, trained peer interventionists successfully delivered a Peer Recovery Support Services (PRSS) intervention, achieving a treatment enrollment success rate between 16% and 60%.

The interventionists reported no negative effects from their role, indicating that peer-led interventions can be implemented safely and effectively with limited training, although further research is needed to understand the factors influencing their varying success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Kropp, F., Wilder, C., Theobald, J., et al.[2022]

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]

Citations

1. link.springer.com link.springer.com/article/10.1007/s40429-025-00645-8

Peer Recovery Support Services and Recovery Coaching ... In this article, we systematically review the research on peer recovery support services (PRSS) for substance use disorder (SUD).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871621006189

Effectiveness of peer recovery support services on stages ... This study systematically synthesized existing literature reporting the effectiveness of PRSS interventions on stages of the OUD treatment cascade.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322658/

Peer support for patients with opioid use disorder in the ... In this narrative review, we synthesize the existing evidence on how to develop and implement peer programs for OUD in the ED setting.

4. mass.gov mass.gov/doc/mgh-recovery-coach-report-submitted-to-recovery-coach-inbox/download

A Systematic Review of Peer Recovery Support Services ... (F= 32.5%, M= 67.5%). 12 months. N/A. Opioids. At 12-month follow-up via medical chart review, groups were not significantly different in terms of proportion of.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1529078/full

Systematizing peer recovery support services for ... Although PRSS research is in its infancy, studies show evidence of PRSS efficacy across certain settings and outcomes (13, 14). A systematic ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460319309049

Peer support specialists and perinatal opioid use disorder Participants reported that PSSs had a strong, positive impact on their recovery. Postpartum women report overall positive experiences receiving peer support ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816733

Emergency Department Peer Support Program and Patient ... In this cohort study of patients treated for opioid overdose, OORP implementation was associated with an increase in MOUD initiation and a decrease in repeat ...