Recruiting

Peer Recovery

Sponsor:

University of Maryland, College Park

Code:

NCT05973838

Conditions

Polysubstance Addiction

Opioid Medication Assisted Treatment

Treatment Adherence

Retention in Care

Substance-Related Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peer-Delivered Behavioral Activation ("Peer Activate")

Study Details

Brief summary:

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

Conditions

Polysubstance Addiction

Opioid Medication Assisted Treatment

Treatment Adherence

Retention in Care

Substance-Related Disorders

Study ID

NCT05973838

Start date

Jun 15, 2023

Status verified date

Apr, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.

Exclusion Criteria:

  • Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
  • Inability to understand the study and provide informed consent in English

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Peer-Delivered Behavioral Activation ("Peer Activate")

Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.

no intervention: Treatment As Usual

Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

Interventions

Peer-Delivered Behavioral Activation ("Peer Activate")

The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.

Primary outcome measure

  • Six-Month Polysubstance Use Urinalysis [ Time Frame: Measured from baseline to 6-month follow-up ]
  • Six-Month Polysubstance Use Self Report [ Time Frame: Assessed between the baseline assessment 6-month follow-up ]

Central Contacts and Locations

Central contacts

Morgan S Anvari, BA

3014055095manvari@umd.edu

Locations

Caroline County Behavioral Health

Recruiting

Denton, Maryland, United States, 21629

Contacts

Jessica Tuel, MSW

410-479-8172jessicam.tuel@maryland.gov

More Information

Sponsor

University of Maryland, College Park

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • Substance-Related Disorders
  • Opioid-Related Disorders
  • Polysubstance Use
  • Mental disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, College Park on 2026-04-27.