NCT05138614 · University of Massachusetts, Worcester
Supporting Treatment Access and Recovery in COD
(STAR-COD)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Medication for Opioid Use Disorder
medication management
BEHAVIORAL
MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
BEHAVIORAL
MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
BEHAVIORAL
MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
Primary outcome measures
Engagement in treatment
Time frame: 6 months
Measured by total days in treatment
Engagement in medication for opioid use disorder (MOUD)
Time frame: 6 months
Measured by percentage of days receiving MOUD
Engagement in outreach and linkage sessions
Time frame: 6 months
Measured by total number of outreach and linkage sessions
Self-report opioid use and other substance use
Time frame: Baseline
Measured by self-report days of use
Self-report opioid use and other substance use
Time frame: 3 months
Measured by self-report days of use
Self-report opioid use and other substance use
Time frame: 6 months
Measured by self-report days of use
Self-report opioid use and other substance use
Time frame: 9 months
Measured by self-report days of use
Self-report opioid use and other substance use
Time frame: 12 months
Measured by self-report days of use
Opioid use and other substance use (drug screen)
Time frame: 3 months
Measured by positive drug screens
Opioid use and other substance use (drug screen)
Time frame: 6 months
Measured by positive drug screens
Mental health functioning
Time frame: Baseline
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Mental health functioning
Time frame: 3 months
Measured by self-report mental health symptoms on BASIS-24
Mental health functioning
Time frame: 6 months
Measured by self-report mental health symptoms on BASIS-24
Mental health functioning
Time frame: 9 months
Measured by self-report mental health symptoms on BASIS-24
Mental health functioning
Time frame: 12 months
Measured by self-report mental health symptoms on BASIS-24
PTSD symptoms
Time frame: Baseline
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD symptoms
Time frame: 3 months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD symptoms
Time frame: 6 months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD symptoms
Time frame: 9 months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
PTSD symptoms
Time frame: 12 months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Mental health impairment
Time frame: Baseline
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Mental health impairment
Time frame: 3 months
Measured by self-report on WHODAS 2.0
Mental health impairment
Time frame: 6 months
Measured by self-report on WHODAS 2.0
Mental health impairment
Time frame: 9 months
Measured by self-report on WHODAS 2.0
Mental health impairment
Time frame: 12 months
Measured by self-report on WHODAS 2.0
Psychiatric severity
Time frame: Baseline
Measured by Structured Clinical Interview for DSM-5 (SCID-RV)
Health functioning
Time frame: Baseline
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Health functioning
Time frame: 3 months
Measured by the WHOQOL-BREF
Health functioning
Time frame: 6 months
Measured by the WHOQOL-BREF
Health functioning
Time frame: 9 months
Measured by the WHOQOL-BREF
Health functioning
Time frame: 12 months
Measured by the WHOQOL-BREF
Motivation for treatment
Time frame: Baseline
Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)
Motivation for treatment
Time frame: 3 months
Measured by SOCRATES
Motivation for treatment
Time frame: 6 months
Measured by SOCRATES
Motivation for treatment
Time frame: 9 months
Measured by SOCRATES
Motivation for treatment
Time frame: 12 months
Measured by SOCRATES
Suicide Severity
Time frame: Baseline
Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)
Suicide Severity
Time frame: 3 months
Measured by C-SSRS
Suicide Severity
Time frame: 6 months
Measured by C-SSRS
Suicide Severity
Time frame: 9 months
Measured by C-SSRS
Suicide Severity
Time frame: 12 months
Measured by C-SSRS
Therapeutic alliance
Time frame: Baseline
Measured by Working Alliance Inventory
Therapeutic alliance
Time frame: 3 months
Measured by Working Alliance Inventory
Therapeutic alliance
Time frame: 6 months
Measured by Working Alliance Inventory
Therapeutic alliance
Time frame: 9 months
Measured by Working Alliance Inventory
Therapeutic alliance
Time frame: 12 months
Measured by Working Alliance Inventory
Recovery Capital
Time frame: Baseline
Measured by Assessment of Recovery Capital
Recovery Capital
Time frame: 3 months
Measured by Assessment of Recovery Capital
Recovery Capital
Time frame: 6 months
Measured by Assessment of Recovery Capital
Recovery Capital
Time frame: 9 months
Measured by Assessment of Recovery Capital
Recovery Capital
Time frame: 12 months
Measured by Assessment of Recovery Capital
Chronic pain
Time frame: Baseline
Measured by Chronic Pain assessment
Chronic pain
Time frame: 3 months
Measured by Chronic Pain assessment
Chronic pain
Time frame: 6 months
Measured by Chronic Pain assessment
Chronic pain
Time frame: 9 months
Measured by Chronic Pain assessment
Chronic pain
Time frame: 12 months
Measured by Chronic Pain assessment
Medication Adherence
Time frame: 3 months
Measured by Medication Adherence Rating Scale
Medication Adherence
Time frame: 6 months
Measured by Medication Adherence Rating Scale
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Holyoke, Massachusetts
- Orange, Massachusetts
- Springfield, Massachusetts
- Worcester, Massachusetts
Collaborators
National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, Cornell University, Harvard Medical School (HMS and HSDM)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations