Supporting Treatment Access and Recovery in COD

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Mental Health Disorder

• Registration Number: NCT05138614
• Lead Sponsor: University of Massachusetts, Worcester

Brief 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.

Detailed Description

This is a 5-arm randomized control trial with a fractional factorial design among 1,000 patients across 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.

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-12-01
• Study Start: 2022-03-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Are 18 years-old and older;
• Are fluent in English or Spanish;
• Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;
• Able to provide consent;
• Potentially have a concurrent substance use disorder in addition to opioids; and
• Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for "a" (i.e., not having a substance use relapse), but they do meet criteria for "b" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.

Exclusion Criteria

• Are not fluent in English or Spanish;
• Are acutely psychotic, acutely suicidal with a plan, or homicidal;
• Are incompetent and unable to provide informed consent; and
• Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of > 10 mg/day; Diazepam > 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Engagement in medication for opioid use disorder (MOUD)	6 months	Measured by percentage of days receiving MOUD
Engagement in outreach and linkage sessions	6 months	Measured by total number of outreach and linkage sessions
Self-report opioid use and other substance use	12 months	Measured by self-report days of use
Opioid use and other substance use (drug screen)	6 months	Measured by positive drug screens
Mental health functioning	12 months	Measured by self-report mental health symptoms on BASIS-24
PTSD symptoms	12 months	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental health impairment	12 months	Measured by self-report on WHODAS 2.0
Psychiatric severity	Baseline	Measured by Structured Clinical Interview for DSM-5 (SCID-RV)
Health functioning	12 months	Measured by the WHOQOL-BREF
Motivation for treatment	12 months	Measured by SOCRATES
Suicide Severity	12 months	Measured by C-SSRS
Therapeutic alliance	12 months	Measured by Working Alliance Inventory
Recovery Capital	12 months	Measured by Assessment of Recovery Capital
Chronic pain	12 months	Measured by Chronic Pain assessment
Medication Adherence	6 months	Measured by Medication Adherence Rating Scale
Engagement in treatment	6 months	Measured by total days in treatment

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months	Data extracted from medical records
Quality Adjusted Life Years (QALYs): health	12 months	Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).
Quality Adjusted Life Years (QALYs): quality of life	12 months	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.

Trial Locations

Locations (3)

Behavioral Health Network; 🇺🇸 Springfield, Massachusetts, United States

UMass Chan Road to Care Clinic; 🇺🇸 Worcester, Massachusetts, United States

SaVida Health; 🇺🇸 Worcester, Massachusetts, United States