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

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Retention in Care; Treatment Adherence; Substance-Related Disorders; Opioid Medication Assisted Treatment; Opioid Use; Opioid Addiction
• Interventions: Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")

• Registration Number: NCT05299515
• Lead Sponsor: University of Maryland, College Park

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-03-29
• Study Start: 2022-04-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer-Delivered Behavioral Activation ("Peer Activate")	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.

Primary Outcome Measures

Name	Time	Method
MT Retention	Measured at final follow up (approximately six-months post-baseline assessment)	Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence	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 Outcome Measures

Name	Time	Method
MT Persistence	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)
Intervention Feasibility Measured by Intervention Initiation	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.
Intervention Acceptability Measured by Intervention Attendance	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.
Intervention Fidelity Measured by Independent Rating	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.
MT Retention	Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)	Defined dichotomously as retention (yes/no) in methadone treatment
Changes in substance use	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)

Trial Locations

Locations (2)

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

University of Maryland College Park; 🇺🇸 College Park, Maryland, United States