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Supporting Treatment Access and Recovery for Co-occurring Opioid Use and Mental Health Disorders (STAR-COD)

HSS Investigator: David Smelson
Funding Agency: NIH
Status: Ongoing

Project Overview: Opioid use disorder (OUD) is a serious public health problem afflicting over two million people in the U.S. Approximately 50% with OUD have a co-occurring mental health disorder (thereafter called COD) that can worsen clinical outcomes, including those treated with medications for OUD (MOUD), the “gold standard” of care. Individuals with COD are vulnerable to repeated substance use relapses, mental illness exacerbations, overdoses, homelessness, and criminal justice involvement, yet only 24% in the U.S. received treatment for both OUD and co-occurring mental health conditions. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. Given the need to improve outcomes among those with COD who receive MOUD and the strengths of MISSION, it is critical to understand the effectiveness of MISSION components (defined as combinations of 2 of the 3 MISSION parts), costs, and the patient profile that would benefit most from the combination. This will assist providers in deciding which components to deploy and ultimately deliver briefer, robust, cost-effective, personalized COD treatment options. This is a 4-year, 5-arm RCT with a half-fraction factorial design among 1,000 patients across MOUD programs. Patients will be randomized to: 1) MOUD alone; 2) full MISSION (CTI & DRT & PS) + MOUD; 3) CTI & DRT + MOUD; 4) PS & DRT + MOUD; or 5) CTI & PS + MOUD (Arms 3-5 are the 3 combinations of 2 MISSION parts). Participants receive 6 months of treatment and be followed for 1-year. Study aims include: Aim 1: To evaluate the effectiveness of MISSION or its bundled parts with MOUD versus MOUD alone, as well as the incremental benefits of MISSION and its parts + MOUD to improve outcomes 1a-c for CODs; Aim 2: To examine mechanisms of action of MISSION in CODs; Aim 3: To conduct a comprehensive economic evaluation of MISSION or its bundled parts and MOUD; and Exploratory Aim: 4. To construct a predictive model that can match optimum combined use of MISSION parts with specific patient’s needs for greater improvements in health outcomes, which will inform a future randomized controlled trial on cost-effective patient-level precision intervention assignment.

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