Peer Recovery Support for Opioid Use Disorder

(PRSS Trial)

Overseen By Marc J Fishman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Potomac Health Foundations

Must not be taking: Buprenorphine, Methadone, XR-naltrexone

Disqualifiers: Recent buprenorphine, methadone, XR-naltrexone

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The United States is experiencing an unprecedented opioid epidemic. Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone, are the recommended standard of care. There are, however, many barriers to MOUD initiation so that only a minority of individuals who could benefit from MOUD treatment ever receive it. Even among individuals presenting to a residential level of specialty SUD care, only about 20% of individuals with OUD initiate MOUD leaving them at a higher risk of opioid relapse, overdose, and death. Thus, the goal of this expansion of scope pilot study is to address this gap by modifying our currently R34-funded intervention (RFA-DA-22-034; Project # 1R34DA057627-01) that leverages the impact of peer recovery support services (PRSS) to promote MOUD initiation. Although PRSS for MOUD initiation shows promise within emergency department settings, the impact of PRSS for MOUD initiation within residential substance use disorder (SUD) settings is unknown. Residential SUD settings are an ideal opportunity to initiate medications because individuals with OUD typically have access to medically-managed withdrawal and the opportunity to learn about and initiate onto MOUD. This PRSS intervention has already been developed in the R34 parent grant to promote MOUD retention, and in this expanded scope project it will be further adapted and tested with a small pilot sample of individuals (N = 10-20) who are further upstream in the cascade of care (COC). Peers will be embedded within the inpatient program unit where the study will take place. Early into their inpatient stay and before MOUD initiation occurs, peers will introduce themselves to patients and provide motivational enhancements for MOUD initiation and inpatient treatment retention through a variety of strategies. Peer strategies will be based on the existing PRSS intervention in the parent grant and may include exploration of MOUD knowledge and attitudes, discussion of relevant lived experience, MOUD psycho-education, and a collaboratively completed wellness plan. Upon discharge, peers will use other strategies to encourage uptake and retention of MOUD such as assertive outreach and emphasize return to care after treatment dropout and/or relapse. The proposed project will explore the feasibility and acceptability of PRSS on MOUD initiation in residential SUD treatment by pilot testing the PRSS intervention with a sample of 10-20 participants receiving an 8-week course of treatment. During the intervention period, the PRSS approach will be adapted and refined with feedback from peer recovery support coaches who have helped develop and test the parent intervention for MOUD retention. Our primary outcomes are: 1) MOUD initiation (yes/no) upon discharge of the inpatient SUD program, and 2) PRSS feasibility and acceptability as measured by a participant satisfaction survey. If this pilot work is successful, the investigators would further test this MOUD initiation-focused version of the PRSS intervention via a future R01-funded Randomized Controlled Trial.

Will I have to stop taking my current medications?

The trial requires that you have not taken sublingual buprenorphine or methadone within 14 days before starting the inpatient treatment, and you must not have received XR-buprenorphine or XR-naltrexone within 45 days before starting. If you are currently on these medications, you may need to stop them before participating.

What data supports the effectiveness of the Peer Recovery Support Services (PRSS) treatment for opioid use disorder?

Research suggests that Peer Recovery Support Services (PRSS) can help people with substance use disorders by reducing substance use, improving relationships with treatment providers, and increasing treatment satisfaction. However, more studies are needed to confirm these benefits and understand how PRSS works best. ^{1 2 3 4 5}

Is Peer Recovery Support for Opioid Use Disorder safe for humans?

A pilot study found that training patients to deliver Peer Recovery Support Services (PRSS) showed no negative effects on the peer interventionists themselves, suggesting it is generally safe for those involved in delivering the intervention. ^{1 2 4 6 7}

How is the Peer Recovery Support Service (PRSS) treatment for opioid use disorder different from other treatments?

The Peer Recovery Support Service (PRSS) treatment is unique because it involves individuals with personal experience in substance use and recovery, known as peer recovery specialists, who provide support and encouragement to patients. This approach helps reduce stigma and improve engagement and retention in medication for opioid use disorder (MOUD) programs, which are common challenges in traditional treatments. ^{1 2 4 7 8}

Eligibility Criteria

This trial is for adults over 18 with Opioid Use Disorder (OUD) who are seeking inpatient treatment at Maryland Treatment Centers, speak English, can consent to the study, and have insurance coverage for Medications for Opioid Use Disorder (MOUD).

Inclusion Criteria

I am over 18, have opioid use disorder, seeking treatment, speak English, can consent, and have insurance for medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week course of Peer Recovery Support Services (PRSS) to promote MOUD initiation during inpatient SUD treatment

8 weeks

Inpatient stay

Follow-up

Participants are monitored for MOUD initiation and retention after discharge from inpatient treatment

4 weeks

Treatment Details

Interventions

• PRSS intervention for MOUD initiation

Trial Overview The trial tests a Peer Recovery Support Services (PRSS) intervention designed to encourage initiation of MOUD during residential substance use disorder treatment. It involves motivational strategies by peers and an 8-week course of treatment.

Participant Groups

Group I: single-arm of an uncontrolled trial of the PRSS intervention for MOUD initiation Experimental Treatment 1 Intervention

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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

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]

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 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]

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]

Peer recovery support services (PRSS) show promise in improving outcomes for individuals with substance use disorder (SUD), including reduced substance use, lower relapse rates, and increased treatment satisfaction, based on a systematic review of various studies.

However, the existing research has significant methodological limitations, such as inconsistent definitions of peer roles and a lack of appropriate comparison groups, highlighting the need for more rigorous studies to better understand the efficacy and implementation of PRSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. Eddie, D., Hoffman, L., Vilsaint, C., et al.[2023]

The Peer Recovery Program implemented in 20 hospitals provided 24/7 support for patients with substance use disorder, receiving referrals during over 30,000 patient visits from 2016 to 2019, with a high acceptance rate of continued support services between 74.8% and 83.0%.

The program demonstrated efficient response times, with Recovery Specialists arriving at the patient's bedside within an average of eight minutes, and facilitated numerous follow-up contacts, although further evidence of improved patient outcomes is necessary for broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing hospital-based peer recovery support services for substance use disorder. Liebling, EJ., Perez, JJS., Litterer, MM., et al.[2021]

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]

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]

References

1. 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]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Implementing hospital-based peer recovery support services for substance use disorder. [2021]

7. 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]

8. 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]