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

NCT06696157 | Recruiting

• 2 other identifiers: 1R34DA057627-01-EXPANDED-SCOPE1R34DA057627-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder

Keywords

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

Outcome Measures

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)

  8 weeks

Secondary Outcomes (3)

• MOUD Initiation after inpatient substance use disorder treatment discharge

  8 weeks

• MOUD Retention

  8 weeks

• Length of inpatient substance abuse treatment stay

  8 weeks

Study Arms (1)

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

EXPERIMENTAL

Behavioral: PRSS intervention for MOUD initiation

Interventions

PRSS intervention for MOUD initiation BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Potomac Health Foundations: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Kevin R Wenzel, PhD

CONTACT

4102331400; KWenzel@marylandtreatment.org

Marc J Fishman, MD

CONTACT

4102331400; Mfishman@marylandtreatment.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: December 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)