Supporting Treatment Access and Recovery in COD — STAR-COD  

Opioid Use Disorder Clinical Trial

Official title: Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders

Status Recruiting

Clinical Trial Summary

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

Clinical Trial Description

This is a 4-year, 5-arm randomized control trial with a fractional factorial design among 1,000 patients across MOUD programs in Massachusetts. 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). 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. Participants will 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.

Hypothesis 1.1: Individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: 1a. Engagement (measured by total days in treatment, percentage of days receiving MOUD, and total number of outreach and linkages sessions); 1b. Opioid use and other substance use (measured by self-report days of use and drug screens); and 1c. Mental health (measured by self-report mental health symptoms).

Hypothesis 1.2: MISSION + MOUD will outperform its parts + MOUD but at least one of the three combinations + MOUD will be at least 75% as effective compared to the full MISSION protocol on outcomes 1a-c.

Aim 2: To examine mechanisms of action of MISSION in CODs. Hypothesis 2.1: The effects of MISSION and its bundled parts on health outcomes (mental health, opioid and other substance use) are mediated by treatment participation and other measures (e.g., recovery capital, psychosocial supports, and quality of life). Hypothesis 2.2: The effects of MISSION and its parts on health outcomes are moderated by key patient characteristics (e.g., demographics, severity of COD, and MOUD type).

Aim 3: To conduct a comprehensive economic evaluation of MISSION or its bundled parts and MOUD.

Estimate cost of full MISSION or its bundled parts compared to MOUD alone, and to evaluate cost-effectiveness and return on investment from multiple perspectives, including patient, clinic, healthcare, taxpayer, and societal.

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. ;

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Opioid Use Disorder
• Opioid-Related Disorders

• NCT number: NCT05138614
• Study type: Interventional
• Source: University of Massachusetts, Worcester
• Contact: David Smelson, PsyD
• Phone: 508-713-5420
• Email: David.Smelson@umassmed.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Completion date: August 31, 2025