NCT05299515

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Maryland, College Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Peer-Delivered Behavioral Activation ("Peer Activate")	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.

Timeline

• Start date: 2022-04-05
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2022-03-29
• Last updated: 2025-10-27

Locations

2 sites across 1 country: United States