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Clinical Trial 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 an underserved, rural area. 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.


Clinical Trial Description

There is a significant burden of opioid and polysubstance use, disproportionately affecting underserved, rural areas of the US. Yet many rural 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 aboard a mobile treatment unit (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD treatment in rural 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 via the TM-MTU 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 rural 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. 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 polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05973838
Study type Interventional
Source University of Maryland, College Park
Contact Morgan S Anvari, BA
Phone 3014055095
Email manvari@umd.edu
Status Recruiting
Phase N/A
Start date June 15, 2023
Completion date September 1, 2027

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