ClinicalTrials.gg
RecruitingNCT06696157PRSSUpdated Apr 4, 2025

EXPANDED SCOPE for Parent Grant Entitled, "Peer Recovery Support Services for Individuals in Recovery Residences on MOUD"

An interventional study of PRSS intervention for MOUD initiation in Opioid Use Disorder, sponsored by Potomac Health Foundations. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Potomac Health Foundations · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

The United States is experiencing an opioid epidemic marked by significant overdose deaths. Although medications for opioid use disorder (MOUD) are efficacious, the rates of MOUD initiation and retention are alarmingly low, with 11% of patients with an OUD diagnosis initiating MOUD and only 3.5% being retained on treatment for a minimum of 6 months. Also, national initiation rates onto MOUD within inpatient substance use disorder (SUD) programs are 18%, which again demonstrates low uptake of MOUD. Supplementing mediation-based treatment with Peer Recovery Support Services (PRSS) may be an effective strategy to encourage MOUD utilization, yet no such evidence-based interventions to specifically improve MOUD initiation and retention currently exist. To address this problem, the ongoing R34 parent grant-funded study (RFA-DA-22-034; Project # 1R34DA057627-01) is developing a new intervention that leverages PRSS to increase MOUD retention in patients living in recovery residences (RRs) and 3.1 residential programs. The parent grant study, however, does not address the aforementioned lagging initiation rates within inpatient SUD treatment programs.

To address this gap, the investigative team is conducting this small pilot study to expand the scope of our parent grant clinical trial to improve MOUD initiation across the OUD cascade of care COC. The ongoing parent grant study's goal is to enhance retention for individuals who have already initiated MOUD and are now living in 3.1 residential programs or Recovery Residences (RRs), which are both further downstream in the OUD COC. This small pilot study will expand the scope of the existing parent project by also utilizing PRSS during inpatient SUD treatment, which is more upstream in the COC.

The rationale for this expansion of scope pilot study is that by recruiting participants who are more stable and further downstream in the OUD COC, the current parent project intervention under investigation misses an opportunity to increase MOUD initiation. Preliminary data gathered from our electronic health record at our institution, Maryland Treatment Centers, showed that only 46% of our inpatients diagnosed with OUD initiate MOUD before leaving inpatient SUD treatment, despite the fact that we recommend MOUD as the first-line standard of care. Furthermore, patients with OUD, which included both premature dropouts and successful program completers, left treatment after an average of two weeks (i.e., 14.89 days). Early dropout limits a patient's opportunities to initiate MOUD and/or become stably retained on MOUD. Thus, investigators will expand the scope of the R34 project to include adapting the existing PRSS intervention for MOUD initiation and obtain pilot data on feasibility in (N = 35) patients enrolled in SUD inpatient treatment. We will accomplish this goal by piloting the PRSS intervention for MOUD initiation during the time that remains for the existing R34 award. All participants will receive the PRSS intervention for a total of 8 weeks.

On important goal of this expanded scope pilot is to explore the feasibility of using PRSS with SUD inpatients. Parent grant Phase 1 qualitative interviews were conducted with stakeholders (N = 16) that included peers (50% of total sample), patients on MOUD (25% of sample), and other professionals working with patients on MOUD (25% of sample) to assess these stakeholders' opinions of the parent grant version of PRSS. Overall, stakeholders found PRSS to be useful and consistent with the tools peers use to help patients adhere to MOUD. The parent grant's rate of recruitment and randomization meets our expected study target goals per month, and demonstrates that the PRSS intervention is feasible with respect to our ability to recruit effectively at Mountain Manor Treatment Center (MMTC), which is under the umbrella of Maryland Treatment Centers and is the study location for this expansion of scope pilot study. Unlike the parent grant that only enrolls patients who are already inducted onto MOUD, this expansion of scope proposal will only recruit people who are in SUD inpatient care and who are not currently on MOUD in an effort to get them to initiate MOUD. In summary, the expanded scope aim is as follows.

Specific Aim: Investigators will pilot an adapted version of the PRSS parent grant intervention that focuses on improving MOUD initiation in a small uncontrolled pilot sample (N = 35) of participants who are being treated further upstream in the OUD COC within an inpatient SUD treatment setting. Hypothesis: Investigators hypothesize that peers and participants will find the modified PRSS intervention to be both acceptable and feasible and that MOUD initiation rates will compare favorably to historical data from our electronic health records.

Impact: The research in this expansion of scope pilot study will contribute to NIDA's overarching mission to ameliorate the ongoing opioid epidemic which continues to be a serious problem in the United States. If successful, this pilot work would be an initial step toward developing an intervention that would help opioid users to initiate MOUD, which is the underutilized standard of care for OUD treatment. This research has great potential to directly reduce the impact of the current opioid epidemic, which is a major public health crisis that continues to plague the USA.

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • Peer Support Specialist
  • Opioid Use Disorder
  • Peer Recovery Support Services
  • Medications for Opioid Use Disorder
  • MOUD
  • Substance Use Disorder
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 35 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Potomac Health Foundations is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18+ (inclusive)
  • Meets diagnostic criteria for OUD
  • Currently seeking inpatient treatment at Maryland Treatment Centers program
  • English speaking
  • Willing and able to provide
  • Able to obtain MOUD through insurance.

Exclusion criteria

Exclusion Criteria:

  • Having been prescribed and taken a maintenance dose of sublingual buprenorphine or methadone within 14 days of entering the current inpatient treatment episode
  • received a dose of XR-buprenorphine or XR-naltrexone within 45 days of entering the current inpatient treatment episode.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    single-arm of an uncontrolled trial of the PRSS intervention for MOUD initiation

    Behavioral: PRSS intervention for MOUD initiation

Interventions

  • BehavioralPRSS intervention for MOUD initiation

    All participants of this expanded scope pilot study will be in a single-arm of an uncontrolled trial of PRSS intervention for MOUD initiation for a total of 8 weeks, starting in inpatient substance abuse treatment. This is distinguished from the R34 parent grant which targets MOUD retention and adherence rather than MOUD initiation.

06

What researchers measure

Primary outcomes

  1. MOUD initiation at inpatient substance abuse treatment discharge

    MOUD initiation status at inpatient substance abuse treatment discharge. Did the participant initiate by the date of discharge? (Yes / No)

    Time frame: 8 weeks

Secondary outcomes

  1. MOUD Initiation after inpatient substance use disorder treatment discharge

    MOUD initiation status at inpatient substance abuse treatment discharge. Did the participant initiate MOUD at any time during the 8 weeks course of the intervention? (Yes / No)

    Time frame: 8 weeks

  2. MOUD Retention

    Among MOUD initiators during inpatient substance abuse treatment, was the participant retained on MOUD at the end of 8 week intervention period? (Yes / No)

    Time frame: 8 weeks

  3. Length of inpatient substance abuse treatment stay

    Number of days retained in inpatient substance abuse treatment care

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Maryland Treatment Centers
    Baltimore, Maryland 21229, United States
    Recruiting
    • Kevin Wenzel, PhD · Contact410-233-1400
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Mar 2026, 15 months after the start.

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 planned 15 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.

Registered
Nov 18, 2024
First posted
Nov 20, 2024
StartActual
Dec 1, 2024
Primary completionEst.
Mar 31, 2026
CompletionEst.
Sep 29, 2026
Last update
Apr 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06696157
Lead sponsor
Potomac Health Foundations
Responsible party
Sponsor
First posted
Nov 20, 2024
Start date
Dec 1, 2024
Primary completion
Mar 31, 2026 (estimated)
Completion
Sep 29, 2026 (estimated)
Last update
Apr 4, 2025

Study contacts

Kevin R Wenzel, PhD
Contact
KWenzel@marylandtreatment.org
4102331400
Marc J Fishman, MD
Contact
Mfishman@marylandtreatment.org
4102331400

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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