Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence

NCT05299515 | Completed DMC

• 1 other identifier: 1816868
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.

Conditions

Substance-Related Disorders; Opioid Medication Assisted Treatment; Opioid Use Disorder; Opioid Use; Opioid Addiction; Treatment Adherence; Retention in Care

Keywords

Disease; Substance-Related Disorders; Opioid-Related Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (2)

• MT Retention

  Defined dichotomously as retention (yes/no) in methadone treatment

  Measured at final follow up (approximately six-months post-baseline assessment)

• MT Persistence

  Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)

  Measured at final follow up (approximately six-months post-baseline)

Secondary Outcomes (6)

• Intervention Feasibility Measured by Intervention Initiation

  Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)

• Intervention Acceptability Measured by Intervention Attendance

  Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)

• Intervention Fidelity Measured by Independent Rating

  Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)

• MT Retention

  Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)

• MT Persistence

  Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)

Other Outcomes (3)

• Change in depressive symptoms

  Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)

• Change in depressive symptoms

  Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)

• Changes in substance use

  Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)

Study Arms (2)

Peer-Delivered Behavioral Activation ("Peer Activate")

EXPERIMENTAL

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.

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

Treatment As Usual

NO INTERVENTION

Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).

Interventions

Peer-Delivered Behavioral Activation ("Peer Activate") BEHAVIORAL

The PRS-delivered Peer Activate intervention will consist of approximately four weekly "core" sessions (approximately 30 minutes-1 hour) with two additional sessions to reinforce core content, and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to assist in their retention and persistence in methadone treatment and incorporating value-driven, substance-free, rewarding activities into their daily life.

Peer-Delivered Behavioral Activation ("Peer Activate")

Eligibility Criteria

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

You may qualify if:

• Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records
• Minimum of 18 years old

You may not qualify if:

• 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
• Positive pregnancy status at enrollment

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Maryland, Baltimore: collaborator
• Henry Ford Health System: collaborator

Study Sites (2)

University of Maryland Baltimore (UMD Drug Treatment Center)

Baltimore, Maryland, 21223, United States

Location

University of Maryland College Park

College Park, Maryland, 20742, United States

Location

Related Publications (21)

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  PMID: 40756389 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Treatment Adherence and Compliance; Disease; Mental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Narcotic-Related Disorders; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica F Magidson, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the approximately 3-Month (or at completion/discontinuation of intervention) and approximately 6-Month Follow-Up assessments (or approximately 3 months after 3-month follow up assessment or at discontinuation of intervention), a trained and blinded member of the research team will complete assessments with the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in parallel to receive either the Peer Activate intervention or treatment as usual (TAU: weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at an approximately 3-month follow-up (or at completion/discontinuation of the intervention), and at an approximately 6-month follow-up (or at 3 months after completion/discontinuation of the intervention).

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 29, 2022
• Study Start: April 5, 2022
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)