Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

NCT ID: NCT05973838

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers.

This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Conditions

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Polysubstance Addiction Opioid Medication Assisted Treatment Treatment Adherence Retention in Care Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
At 3-month, 6-month and 12-months following the baseline assessment, a trained and randomization-blinded member of the research team will complete assessments with the participant.

Study Groups

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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.

Group Type EXPERIMENTAL

Peer-Delivered Behavioral Activation ("Peer Activate")

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role lead

Responsible Party

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Jessica Magidson

Director and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica F Magidson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Sarah M Kattakuzhy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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HIPS Clinic

Washington D.C., District of Columbia, United States

Site Status NOT_YET_RECRUITING

University of Maryland Baltimore (UMD Drug Treatment Center)

Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

University of Maryland, College Park

College Park, Maryland, United States

Site Status NOT_YET_RECRUITING

Caroline County Behavioral Health

Denton, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Morgan S Anvari, BA

Role: CONTACT

3014055095

Facility Contacts

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Sarah M. Kattakuzhy, MD

Role: primary

443-691-4638

Heather Fitzsimons

Role: primary

443-462-3400

Morgan S Anvari, BA

Role: primary

3014055095

Jessica F Magidson, PhD

Role: backup

301-405-5095

Jessica Tuel, MSW

Role: primary

410-479-8172

References

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Other Identifiers

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R01DA057443

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1953327

Identifier Type: -

Identifier Source: org_study_id

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