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Completed

NCT Number: NCT05299515

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

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.

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Key information

Conditions

Substance-related Disorders Behavior Chemically-Induced Disorders Disease Health Behavior Mental Disorders Narcotic-Related Disorders Opioid Addiction Opioid Medication Assisted Treatment Opioid Use Opioid Use Disorder Opioid-Related Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Retention in Care Treatment Adherence Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Baltimore (UMD Drug Treatment Center), Baltimore, Maryland, United States

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About this study

The opioid use disorder (OUD) crisis disproportionately affects low-income, racial/ethnic minorities. There is a pressing need to improve retention in medication for opioid use disorder (MOUD), particularly among low-income, racial/ethnic minorities. Training peer recovery specialists (PRSs), individuals with their own lived experience with substance use disorder (SUD), in evidence-based interventions (EBIs) may be a promising strategy to improve MOUD retention for low-income, minority individuals with OUD. Yet, few EBIs have been evaluated for PRS delivery to promote MOUD retention.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, 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. Importantly for implementation, BA also is feasible and cost-effective using lay counselor delivery. Following from this prior research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model.

This Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) builds upon our team's formative work, as well as our recent open label-pilot (R61AT010799) to develop and pilot the PRS-delivered BA approach. Guided by Aarons' stage model and Proctor's model of implementation, we proposed a mixed-methods, Type 1 hybrid effectiveness-implementation study to evaluate implementation and the effectiveness of the intervention on MT retention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • Positive pregnancy status at enrollment

Treatment and study plan

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.

Primary outcomes

  1. MT Retention

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

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

  2. MT Persistence

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

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

Secondary outcomes

  1. Intervention Feasibility Measured by Intervention Initiation

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

    Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. We will also collect qualitative feedback relating to feasibility.

  2. Intervention Acceptability Measured by Intervention Attendance

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

    Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability.

  3. Intervention Fidelity Measured by Independent Rating

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

    Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and we will assess the % of intervention components delivered as intended.

  4. MT Retention

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

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

  5. MT Persistence

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

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

  6. Changes in substance use

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

    Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)

Other outcomes

  1. Change in depressive symptoms

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

    Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.

  2. Change in depressive symptoms

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

    Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.

  3. Changes in substance use

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

    Assess prevalence of opioid use and other substance use (urinalysis and timeline followback)

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • Henry Ford Health System
  • University of Maryland, Baltimore

Registry information

Official study title

Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD

Acronym: HEAL Together

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2022
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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