Peer Recovery Support Services for Individuals in Recovery Residences on MOUD

September 21, 2023 updated by: Potomac Health Foundations

The United States is experiencing an unprecedented opioid epidemic with a rapid increase in overdose deaths. Medications for opioid use disorder (MOUD) including methadone, buprenorphine, and extended-release naltrexone are efficacious and the recommended standard of care, yet barriers to sustained MOUD treatment reduce the overall efficacy of MOUD. Rates of MOUD retention are alarmingly low and MOUD dropout predicts opioid use/relapse, overdose, and death. While previous research has identified predictors of MOUD retention and adherence, there are no evidence-based interventions to improve MOUD retention.

Recovery support services are a broad set of strategies to promote healthy outcomes among individuals with substance use disorder (SUD) that are typically separate from standard professional treatment. Among those strategies most utilized are peer recovery support services (PRSS) and recovery residences (RRs). PRSS include coaching, mentoring, education, and other supports delivered by individuals uniquely qualified by their lived experience with SUD. PRSS are increasingly utilized in a range of clinical settings, and advantages of PRSS include inherent shared understanding of addiction and a high degree of acceptance and understanding that is not found in most professional relationships. Existing research tentatively supports PRSS; however, the evidence to date is sparse and comes with significant methodological limitations and inconsistencies that make it difficult to conclude the efficacy of PRSS. No studies have examined the role of PRSS in promoting retention in MOUD. RRs provide a supportive living environment for persons in recovery from SUD and are widely utilized in the United States with an estimated 17,943 residences in 2020. Despite their proliferation, the evidence for RRs is only moderate and diminished by methodological weaknesses. Further, individuals on MOUD seeking housing through RRs often face increased MOUD-related stigma or may be disqualified from a RR for taking MOUD and need additional support to navigate these challenges.

The potential synergistic benefits of combining PRSS and RRs to improve MOUD retention are considerable. PRSS and RRs are already mainstays in the recovery support services repertoire and could be leveraged to support MOUD retention. For example, more frequent, informal outreach typical of PRSS could facilitate regular monitoring of shifting attitudes and behaviors related to MOUD. The structure and accountability embedded in RRs could be used to support MOUD adherence and retention. Waxing and waning motivation to participate in MOUD treatment is common, and standard treatment is often unsuccessful at identifying early signs of future dropout or facilitating re-engagement after dropout.

We will recruit participants on MOUD in RRs and provide them with PRSS using approaches such as recovery coaching and care navigation with a particular focus on supporting retention in MOUD care. PRSS will also provide assertive outreach between episodes of care, emphasize continuation in treatment and other recovery activities after leaving a RR (either successfully or unsuccessfully), and emphasize return to care after treatment dropout and/or relapse. The peers will be deeply embedded within the local provider community and care continuum to facilitate ease of care navigation. The ultimate goal of our research agenda is to test the efficacy of a PRSS intervention among individuals with OUD living in RRs through a rigorous trial. The eventual trial design would be informed by preparatory activities and experience proposed in this planning project.

Preparatory activities proposed in this project include three major phases. Phase 1 - preparation for the intervention including: building a network of RRs that will be recruitment sites in the pilot RCT, recruiting and training peer support specialists, conducting focus groups and interviews to gather stakeholder input, and developing PRSS approaches to promote MOUD retention. Phase 2 - pilot test the PRSS intervention by randomizing N=50 individuals on MOUD recruited from collaborating RRs to either: a 24-week course of the PRSS intervention added to usual services, or usual services without the PRSS intervention. Phase 3 - gather additional input from former participants and RR staff post-intervention to further refine the intervention, and use lessons learned to inform our trial design and data collection procedures for the next-step R01 application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21229
      • Rockville, Maryland, United States, 20853
        • Recruiting
        • Maryland Treatment Centers/Avery Road Treatment Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18+ (inclusive); meets diagnostic criteria for OUD; residing at a RR affiliated with this study; seeking treatment with and successfully inducted onto MOUD (i.e., XR-NTX, SL-BUP, XR-BUP, or methadone); English speaking; willing and able to provide informed consent.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 Title: Treatment as Usual (TAU)
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.
Behavioral: Treatment as Usual (TAU) (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.
Experimental: Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU
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.
Behavioral: Peer Recovery Support Services (PRSS) + TAU (experimental- 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative MOUD retention
Time Frame: Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).
Primary Outcome: Cumulative MOUD retention on all follow-up assessments for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome 1- continuous MOUD retention ("yes" or "no")
Time Frame: Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Continuous MOUD retention on all follow-up assessments will be tracked for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Secondary Outcome 2- opioid relapse ("yes" or "no")
Time Frame: Relapse is defined as ten days of use within a 4-week period.
Opioid relapse are measured by tracking responses on the following data sources: Time Line Follow Back.
Relapse is defined as ten days of use within a 4-week period.
Secondary Outcome 3- re-initiation of MOUD after dropout ("yes" or "no")
Time Frame: Re-initiation of MOUD is defined as re-initiation onto any MOUD for at least 7 days after MOUD dropout (defined as >14 days without MOUD).
Re-initiation of MOUD after dropout will be measured by examining all follow-up assessments after dropout for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Re-initiation of MOUD is defined as re-initiation onto any MOUD for at least 7 days after MOUD dropout (defined as >14 days without MOUD).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potomac Health Foundations

Collaborators

National Institutes of Health (NIH)
National Institute of Drug Abuse

Investigators

  • Principal Investigator: Kevin R. Wenzel, Ph.D., Mountain Manor Treatment Center - Maryland Treatment Centers
  • Principal Investigator: Marc J. Fishman, M.D., Mountain Manor Treatment Center - Maryland Treatment Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

September 29, 2025

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DA057627-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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