An interventional study of Treatment as Usual (TAU) (Arm 1) and Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2) in Opioid Use Disorder and Substance Use Disorder, sponsored by Potomac Health Foundations. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Potomac Health Foundations · Not applicable, Interventional, and Treatment
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 50 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Potomac Health Foundations is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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) 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
cumulative MOUD retention
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.
Time frame: Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).
Secondary Outcome 1- continuous MOUD retention ("yes" or "no")
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.
Time frame: Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Secondary Outcome 2- opioid relapse ("yes" or "no")
Opioid relapse are measured by tracking responses on the following data sources: Time Line Follow Back.
Time frame: 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")
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.
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).
Plan to share: No
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Ran from Jul 2023 to primary completion in Apr 2025, 20 months.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 20 months is below that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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