Clinical trial NCT05299515: Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence
Official title: Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: Henry Ford Health System
First posted: 2022-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MT Retention
timeFrame: Measured at final follow up (approximately six-months post-baseline assessment)
measure: MT Persistence
timeFrame: Measured at final follow up (approximately six-months post-baseline)
Secondary outcomes:
measure: Intervention Feasibility Measured by Intervention Initiation
timeFrame: Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
measure: Intervention Acceptability Measured by Intervention Attendance
timeFrame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
measure: Intervention Fidelity Measured by Independent Rating
timeFrame: Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
measure: MT Retention
timeFrame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
measure: MT Persistence
timeFrame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
measure: Changes in substance use
timeFrame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Other outcomes:
measure: Change in depressive symptoms
timeFrame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
measure: Change in depressive symptoms
timeFrame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
measure: Changes in substance use
timeFrame: Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore (UMD Drug Treatment Center)
state: Maryland
city: College Park
country: United States
facility: University of Maryland College Park
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
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