NCT06696157: PRSS

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

Recruiting now NA Last updated 4 April 2025

What this trial tests

NA trial testing PRSS intervention for MOUD initiation in Opioid Use Disorder in 35 participants. Currently enrolling.

Timeline

1 December 2024

Primary endpoint
31 March 2026

29 September 2026

Quick facts

Lead sponsor	Potomac Health Foundations
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 December 2024
Primary completion	31 March 2026
Estimated completion	29 September 2026
Sites	1 location across United States

Drugs / interventions tested

• PRSS intervention for MOUD initiation

Conditions studied

• Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Potomac Health Foundations

Who can join

18 and older, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.