Supporting Treatment Access and Recovery in COD (STAR-COD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health Disorder; Opioid Use Disorder
• Intervention / Treatment: Other: Medication for Opioid Use Disorder; Behavioral: MISSION Critical Time Intervention; Behavioral: MISSION Peer Support; Behavioral: MISSION Dual Recovery Therapy

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Helm, PhD; Phone Number: 413-313-2806; Email: Abigail.Helm@umassmed.edu
• Study Contact Backup: Name: David Smelson, PsyD; Phone Number: 508-713-5420; Email: David.Smelson@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Holyoke, Massachusetts, United States, 01040
      • Recruiting
      • Behavioral Health Network
      • Contact: Herschelle Reaves
    • Orange, Massachusetts, United States, 01364
      • Recruiting
      • Behavioral Health Network
      • Contact: Calla Harrington; Email: calla.harrington@bhninc.org
    • Springfield, Massachusetts, United States, 01104
      • Recruiting
      • Behavioral Health Network
      • Contact: Herschelle Reaves; Email: herschelle.reaves@bhninc.org
    • Worcester, Massachusetts, United States, 01601
      • Recruiting
      • UMass Chan Road to Care Clinic
      • Contact: Brittany Chapman; Email: brittany.chapman@umassmed.edu
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • SaVida Health
      • Contact: Shelley Modzeleski; Email: s.modzeleski@savidahealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full MISSION; CTI + DRT + PS + MOUD	Other: Medication for Opioid Use Disorder; medication management; Other Names: MOUD; Behavioral: MISSION Critical Time Intervention; offering intensive community-based services that decrease in intensity over time; Other Names: CTI; Behavioral: MISSION Peer Support; including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders; Other Names: PS; Behavioral: MISSION Dual Recovery Therapy; comprised of 13 structured co-occurring disorders treatment sessions; Other Names: DRT
Experimental: CTI & DRT; CTI + DRT + MOUD	Other: Medication for Opioid Use Disorder; medication management; Other Names: MOUD; Behavioral: MISSION Critical Time Intervention; offering intensive community-based services that decrease in intensity over time; Other Names: CTI; Behavioral: MISSION Dual Recovery Therapy; comprised of 13 structured co-occurring disorders treatment sessions; Other Names: DRT
Experimental: CTI & PS; CTI + PS + MOUD	Other: Medication for Opioid Use Disorder; medication management; Other Names: MOUD; Behavioral: MISSION Critical Time Intervention; offering intensive community-based services that decrease in intensity over time; Other Names: CTI; Behavioral: MISSION Peer Support; including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders; Other Names: PS
Experimental: DRT & PS; DRT + PS + MOUD	Other: Medication for Opioid Use Disorder; medication management; Other Names: MOUD; Behavioral: MISSION Peer Support; including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders; Other Names: PS; Behavioral: MISSION Dual Recovery Therapy; comprised of 13 structured co-occurring disorders treatment sessions; Other Names: DRT
Other: MOUD only; MOUD	Other: Medication for Opioid Use Disorder; medication management; Other Names: MOUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	Baseline
Engagement in treatment	Measured by total days in treatment	6 months
Engagement in medication for opioid use disorder (MOUD)	Measured by percentage of days receiving MOUD	6 months
Engagement in outreach and linkage sessions	Measured by total number of outreach and linkage sessions	6 months
Self-report opioid use and other substance use	Measured by self-report days of use	Baseline
Self-report opioid use and other substance use	Measured by self-report days of use	3 months
Self-report opioid use and other substance use	Measured by self-report days of use	6 months
Self-report opioid use and other substance use	Measured by self-report days of use	9 months
Self-report opioid use and other substance use	Measured by self-report days of use	12 months
Opioid use and other substance use (drug screen)	Measured by positive drug screens	3 months
Opioid use and other substance use (drug screen)	Measured by positive drug screens	6 months
Mental health functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	Baseline
Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	3 months
Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	6 months
Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	9 months
Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	12 months
PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	Baseline
PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	3 months
PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	6 months
PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	9 months
PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	12 months
Mental health impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	Baseline
Mental health impairment	Measured by self-report on WHODAS 2.0	3 months
Mental health impairment	Measured by self-report on WHODAS 2.0	6 months
Mental health impairment	Measured by self-report on WHODAS 2.0	9 months
Mental health impairment	Measured by self-report on WHODAS 2.0	12 months
Psychiatric severity	Measured by Structured Clinical Interview for DSM-5 (SCID-RV)	Baseline
Health functioning	Measured by the WHOQOL-BREF	3 months
Health functioning	Measured by the WHOQOL-BREF	6 months
Health functioning	Measured by the WHOQOL-BREF	9 months
Health functioning	Measured by the WHOQOL-BREF	12 months
Motivation for treatment	Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)	Baseline
Motivation for treatment	Measured by SOCRATES	3 months
Motivation for treatment	Measured by SOCRATES	6 months
Motivation for treatment	Measured by SOCRATES	9 months
Motivation for treatment	Measured by SOCRATES	12 months
Suicide Severity	Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)	Baseline
Suicide Severity	Measured by C-SSRS	3 months
Suicide Severity	Measured by C-SSRS	6 months
Suicide Severity	Measured by C-SSRS	9 months
Suicide Severity	Measured by C-SSRS	12 months
Therapeutic alliance	Measured by Working Alliance Inventory	Baseline
Therapeutic alliance	Measured by Working Alliance Inventory	3 months
Therapeutic alliance	Measured by Working Alliance Inventory	6 months
Therapeutic alliance	Measured by Working Alliance Inventory	9 months
Therapeutic alliance	Measured by Working Alliance Inventory	12 months
Recovery Capital	Measured by Assessment of Recovery Capital	Baseline
Recovery Capital	Measured by Assessment of Recovery Capital	3 months
Recovery Capital	Measured by Assessment of Recovery Capital	6 months
Recovery Capital	Measured by Assessment of Recovery Capital	9 months
Recovery Capital	Measured by Assessment of Recovery Capital	12 months
Chronic pain	Measured by Chronic Pain assessment	Baseline
Chronic pain	Measured by Chronic Pain assessment	3 months
Chronic pain	Measured by Chronic Pain assessment	6 months
Chronic pain	Measured by Chronic Pain assessment	9 months
Chronic pain	Measured by Chronic Pain assessment	12 months
Medication Adherence	Measured by Medication Adherence Rating Scale	3 months
Medication Adherence	Measured by Medication Adherence Rating Scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Data extracted from medical records	6 months
Quality Adjusted Life Years (QALYs): health	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).	Baseline
Quality Adjusted Life Years (QALYs): health	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).	3 months
Quality Adjusted Life Years (QALYs): health	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).	6 months
Quality Adjusted Life Years (QALYs): health	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).	9 months
Quality Adjusted Life Years (QALYs): health	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).	12 months
Quality Adjusted Life Years (QALYs): quality of life	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.	Baseline
Quality Adjusted Life Years (QALYs): quality of life	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.	3 months
Quality Adjusted Life Years (QALYs): quality of life	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.	6 months
Quality Adjusted Life Years (QALYs): quality of life	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.	9 months
Quality Adjusted Life Years (QALYs): quality of life	Measured by self-report on Patient Reported Outcomes - Preference (PROPr). Scores range from 0 to 100 with higher scores indicating worse quality of life.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic impact of full MISSION	Cost of full MISSION and MOUD measured by Patient-Reported Outcomes Measurement Information System-Preference (PROPr)	6 months
Economic impact of CTI & PS	Cost of MISSION CTI, PS, and MOUD measured by PROPr	6 months
Economic impact of CTI & DRT	Cost of MISSION CTI, DRT, and MOUD measured by PROPr	6 months
Economic impact of PS & DRT	Cost of MISSION PS, DRT, and MOUD measured by PROPr	6 months
Economic impact of MOUD alone	Cost of MOUD alone measured by PROPr	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Harvard Medical School (HMS and HSDM); National Institute of Mental Health (NIMH); Cornell University; University of Massachusetts, Lowell
• Investigators: Principal Investigator: David Smelson, PsyD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: mental health; opioid use disorder
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Personal Satisfaction; Opioid-Related Disorders; Mental Disorders; Psychological Well-Being; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Dosage Forms
• Other Study ID Numbers: H00023911; 1R01MH128904 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Consistent with the NIH HEAL Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through twice-yearly submissions to the NIMH Data Archive (NDA). In consultation with the University of Massachusetts Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the HEAL Initiative Public Access and Data Sharing Policy.
• IPD Sharing Time Frame: Data will be available upon publication (via an NDA Study) or 1-2 years after the grant end date (August 2026), until 2032 (expiration of NDA Certificate of Confidentiality)
• IPD Sharing Access Criteria: Data will be shared with authorized NDA users.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No