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Trials / Recruiting

RecruitingNCT05973838

Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
180 (estimated)
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) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

Detailed description

There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, 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. BA has been shown to be feasibly delivered by peers and community health workers. This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPeer-Delivered Behavioral Activation ("Peer Activate")The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.

Timeline

Start date
2023-06-15
Primary completion
2027-07-01
Completion
2027-09-01
First posted
2023-08-03
Last updated
2025-10-08

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05973838. Inclusion in this directory is not an endorsement.