RecruitingNCT05138614STAR-CODUpdated Jun 4, 2026

Supporting Treatment Access and Recovery in COD

An interventional study of Medication for Opioid Use Disorder and MISSION Critical Time Intervention in Opioid Use Disorder and Mental Health Disorder, sponsored by University of Massachusetts, Worcester. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Mar 2022; still recruiting 4 years 6 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 1,000
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Opioid Use Disorder
Mental Health Disorder

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Keywords

opioid use disorder
mental health

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Single (Outcomes assessor)
Enrollment: 1,000 participants (estimated)

Study arms

Experimental
Full MISSION
CTI + DRT + PS + MOUD
Other: Medication for Opioid Use Disorder · Behavioral: MISSION Critical Time Intervention · Behavioral: MISSION Peer Support · Behavioral: MISSION Dual Recovery Therapy
Experimental
CTI & DRT
CTI + DRT + MOUD
Other: Medication for Opioid Use Disorder · Behavioral: MISSION Critical Time Intervention · Behavioral: MISSION Dual Recovery Therapy
Experimental
CTI & PS
CTI + PS + MOUD
Other: Medication for Opioid Use Disorder · Behavioral: MISSION Critical Time Intervention · Behavioral: MISSION Peer Support
Experimental
DRT & PS
DRT + PS + MOUD
Other: Medication for Opioid Use Disorder · Behavioral: MISSION Peer Support · Behavioral: MISSION Dual Recovery Therapy
Other
MOUD only
MOUD
Other: Medication for Opioid Use Disorder

Interventions

OtherMedication for Opioid Use Disorder
medication management
Also known as: MOUD
BehavioralMISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
Also known as: CTI
BehavioralMISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
Also known as: PS
BehavioralMISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
Also known as: DRT

What researchers measure

Primary outcomes

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

Secondary outcomes

Mortality
Data extracted from medical records
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months

Other outcomes

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

Study locations

5 of 5 sites recruiting

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

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05138614
Lead sponsor: University of Massachusetts, Worcester
Collaborators: National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, Cornell University, Harvard Medical School (HMS and HSDM)
Responsible party: David Smelson (Professor, University of Massachusetts, Worcester) — Principal investigator
First posted: Dec 1, 2021
Start date: Mar 11, 2022
Primary completion: Aug 31, 2026 (estimated)
Completion: Aug 31, 2026 (estimated)
Last update: Jun 4, 2026

Study contacts

David Smelson, PsyD

Contact

David.Smelson@umassmed.edu

508-713-5420

Abigail Helm, PhD

Contact

Abigail.Helm@umassmed.edu

413-313-2806

David Smelson, PsyD

principal investigator · University of Massachusetts, Worcester

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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