An interventional study of Peer-Delivered Behavioral Activation ("Peer Activate") in Substance-Related Disorders, Opioid Medication Assisted Treatment and Opioid Use Disorder, sponsored by University of Maryland, College Park. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.
Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 200 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
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Exclusion Criteria:
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")
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).
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.
MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
Time frame: 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)
Time frame: Measured at final follow up (approximately six-months post-baseline)
Intervention Feasibility Measured by Intervention Initiation
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.
Time frame: Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Acceptability Measured by Intervention Attendance
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.
Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Fidelity Measured by Independent Rating
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.
Time frame: Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
Time frame: Measured at the acute posttreatment follow-up (approximately 3-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)
Time frame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Changes in substance use
Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)
Time frame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Change in depressive symptoms
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Time frame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Change in depressive symptoms
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Time frame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Changes in substance use
Assess prevalence of opioid use and other substance use (urinalysis and timeline followback)
Time frame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Plan to share: Yes — After all primary analyses are complete, de-identified data will be made available.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of Maryland, College Park