Opioid Use DisorderSTAR-CODNCT05138614
Supporting Treatment Access and Recovery in COD
A study testing Medication for Opioid Use Disorder, MISSION Critical Time Intervention and MISSION Peer Support in people with Opioid Use Disorder and Mental Health Disorder, run by University of Massachusetts, Worcester at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Mental Health Disorder
- What is being tested?
- Medication for Opioid Use Disorder, MISSION Critical Time Intervention and MISSION Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Mar 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Behavioral Health Network
Holyoke, Massachusetts, 01040
Herschelle Reaves
- Recruiting
Behavioral Health Network
Orange, Massachusetts, 01364
Calla Harrington, calla.harrington@bhninc.org
- Recruiting
Behavioral Health Network
Springfield, Massachusetts, 01104
Herschelle Reaves, herschelle.reaves@bhninc.org
- Recruiting
UMass Chan Road to Care Clinic
Worcester, Massachusetts, 01601
Brittany Chapman, brittany.chapman@umassmed.edu
- Recruiting
SaVida Health
Worcester, Massachusetts, 01605
Shelley Modzeleski, s.modzeleski@savidahealth.com
About this study
Official title: 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.
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
- Opioid Use Disorder, Mental Health Disorder
- Being tested
- Medication for Opioid Use Disorder, MISSION Critical Time Intervention, MISSION Peer Support, MISSION Dual Recovery Therapy
- Keywords
- opioid use disorder, mental health
- Medical subject headings
- Opioid-Related Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication for Opioid Use DisorderOther
Also called MOUD
medication management
MISSION Critical Time InterventionBehavioural
Also called CTI
offering intensive community-based services that decrease in intensity over time
MISSION Peer SupportBehavioural
Also called PS
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
MISSION Dual Recovery TherapyBehavioural
Also called DRT
comprised of 13 structured co-occurring disorders treatment sessions
| Study group | Role | What they receive |
|---|---|---|
| Full MISSION | Experimental | CTI + DRT + PS + MOUD Receives: Other: Medication for Opioid Use Disorder; Behavioral: MISSION Critical Time Intervention; Behavioral: MISSION Peer Support; Behavioral: MISSION Dual Recovery Therapy |
| CTI & DRT | Experimental | CTI + DRT + MOUD Receives: Other: Medication for Opioid Use Disorder; Behavioral: MISSION Critical Time Intervention; Behavioral: MISSION Dual Recovery Therapy |
| CTI & PS | Experimental | CTI + PS + MOUD Receives: Other: Medication for Opioid Use Disorder; Behavioral: MISSION Critical Time Intervention; Behavioral: MISSION Peer Support |
| DRT & PS | Experimental | DRT + PS + MOUD Receives: Other: Medication for Opioid Use Disorder; Behavioral: MISSION Peer Support; Behavioral: MISSION Dual Recovery Therapy |
| MOUD only | Other | MOUD Receives: Other: Medication for Opioid Use Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in treatment
Measured by total days in treatment
Measured: 6 months
Engagement in medication for opioid use disorder (MOUD)
Measured by percentage of days receiving MOUD
Measured: 6 months
Engagement in outreach and linkage sessions
Measured by total number of outreach and linkage sessions
Measured: 6 months
Self-report opioid use and other substance use
Measured by self-report days of use
Measured: Baseline
Self-report opioid use and other substance use
Measured by self-report days of use
Measured: 3 months
Self-report opioid use and other substance use
Measured by self-report days of use
Measured: 6 months
Self-report opioid use and other substance use
Measured by self-report days of use
Measured: 9 months
Self-report opioid use and other substance use
Measured by self-report days of use
Measured: 12 months
Opioid use and other substance use (drug screen)
Measured by positive drug screens
Measured: 3 months
Opioid use and other substance use (drug screen)
Measured by positive drug screens
Measured: 6 months
Mental health functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Measured: Baseline
Mental health functioning
Measured by self-report mental health symptoms on BASIS-24
Measured: 3 months
Mental health functioning
Measured by self-report mental health symptoms on BASIS-24
Measured: 6 months
Mental health functioning
Measured by self-report mental health symptoms on BASIS-24
Measured: 9 months
Mental health functioning
Measured by self-report mental health symptoms on BASIS-24
Measured: 12 months
PTSD symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: Baseline
PTSD symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 3 months
PTSD symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 6 months
PTSD symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 9 months
PTSD symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Measured: 12 months
Mental health impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Measured: Baseline
Mental health impairment
Measured by self-report on WHODAS 2.0
Measured: 3 months
Mental health impairment
Measured by self-report on WHODAS 2.0
Measured: 6 months
Mental health impairment
Measured by self-report on WHODAS 2.0
Measured: 9 months
Mental health impairment
Measured by self-report on WHODAS 2.0
Measured: 12 months
Psychiatric severity
Measured by Structured Clinical Interview for DSM-5 (SCID-RV)
Measured: Baseline
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Measured: Baseline
Health functioning
Measured by the WHOQOL-BREF
Measured: 3 months
Health functioning
Measured by the WHOQOL-BREF
Measured: 6 months
Health functioning
Measured by the WHOQOL-BREF
Measured: 9 months
Health functioning
Measured by the WHOQOL-BREF
Measured: 12 months
Motivation for treatment
Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)
Measured: Baseline
Motivation for treatment
Measured by SOCRATES
Measured: 3 months
Motivation for treatment
Measured by SOCRATES
Measured: 6 months
Motivation for treatment
Measured by SOCRATES
Measured: 9 months
Motivation for treatment
Measured by SOCRATES
Measured: 12 months
Suicide Severity
Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline
Suicide Severity
Measured by C-SSRS
Measured: 3 months
Suicide Severity
Measured by C-SSRS
Measured: 6 months
Suicide Severity
Measured by C-SSRS
Measured: 9 months
Suicide Severity
Measured by C-SSRS
Measured: 12 months
Therapeutic alliance
Measured by Working Alliance Inventory
Measured: Baseline
Therapeutic alliance
Measured by Working Alliance Inventory
Measured: 3 months
Therapeutic alliance
Measured by Working Alliance Inventory
Measured: 6 months
Therapeutic alliance
Measured by Working Alliance Inventory
Measured: 9 months
Therapeutic alliance
Measured by Working Alliance Inventory
Measured: 12 months
Recovery Capital
Measured by Assessment of Recovery Capital
Measured: Baseline
Recovery Capital
Measured by Assessment of Recovery Capital
Measured: 3 months
Recovery Capital
Measured by Assessment of Recovery Capital
Measured: 6 months
Recovery Capital
Measured by Assessment of Recovery Capital
Measured: 9 months
Recovery Capital
Measured by Assessment of Recovery Capital
Measured: 12 months
Chronic pain
Measured by Chronic Pain assessment
Measured: Baseline
Chronic pain
Measured by Chronic Pain assessment
Measured: 3 months
Chronic pain
Measured by Chronic Pain assessment
Measured: 6 months
Chronic pain
Measured by Chronic Pain assessment
Measured: 9 months
Chronic pain
Measured by Chronic Pain assessment
Measured: 12 months
Medication Adherence
Measured by Medication Adherence Rating Scale
Measured: 3 months
Medication Adherence
Measured by Medication Adherence Rating Scale
Measured: 6 months
Secondary outcomes (11)
Mortality
Data extracted from medical records
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Mar 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, Cornell University, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, David Smelson, University of Massachusetts, Worcester
- Investigators
- David Smelson, PsyD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138614
- Sponsor's protocol ID
- H00023911
- Other IDs
- 1R01MH128904
- Acronym
- STAR-COD
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders
- ClinicalTrials.gov ID
- NCT05138614
- Acronym / sponsor ID
- STAR-COD / H00023911
- Conditions
- Opioid Use Disorder, Mental Health Disorder
- Keywords
- opioid use disorder, mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, Cornell University, Harvard Medical School (HMS and HSDM)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Full MISSION | Experimental | Other: Medication for Opioid Use Disorder, Behavioral: MISSION Critical Time Intervention, Behavioral: MISSION Peer Support, Behavioral: MISSION Dual Recovery TherapyCTI + DRT + PS + MOUD |
| CTI & DRT | Experimental | Other: Medication for Opioid Use Disorder, Behavioral: MISSION Critical Time Intervention, Behavioral: MISSION Dual Recovery TherapyCTI + DRT + MOUD |
| CTI & PS | Experimental | Other: Medication for Opioid Use Disorder, Behavioral: MISSION Critical Time Intervention, Behavioral: MISSION Peer SupportCTI + PS + MOUD |
| DRT & PS | Experimental | Other: Medication for Opioid Use Disorder, Behavioral: MISSION Peer Support, Behavioral: MISSION Dual Recovery TherapyDRT + PS + MOUD |
| MOUD only | Other | Other: Medication for Opioid Use DisorderMOUD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication for Opioid Use DisorderAlso: MOUDmedication management | Other | CTI & DRT, CTI & PS, DRT & PS, Full MISSION, MOUD only |
| MISSION Critical Time InterventionAlso: CTIoffering intensive community-based services that decrease in intensity over time | Behavioural | CTI & DRT, CTI & PS, Full MISSION |
| MISSION Peer SupportAlso: PSincluding 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders | Behavioural | CTI & PS, DRT & PS, Full MISSION |
| MISSION Dual Recovery TherapyAlso: DRTcomprised of 13 structured co-occurring disorders treatment sessions | Behavioural | CTI & DRT, DRT & PS, Full MISSION |
Primary outcome
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
11 secondary outcomes
Mortality
Time frame: 6 months
Quality Adjusted Life Years (QALYs): health
Time frame: Baseline
Quality Adjusted Life Years (QALYs): health
Time frame: 3 months
Quality Adjusted Life Years (QALYs): health
Time frame: 6 months
Quality Adjusted Life Years (QALYs): health
Time frame: 9 months
Quality Adjusted Life Years (QALYs): health
Time frame: 12 months
Quality Adjusted Life Years (QALYs): quality of life
Time frame: Baseline
Quality Adjusted Life Years (QALYs): quality of life
Time frame: 3 months
Quality Adjusted Life Years (QALYs): quality of life
Time frame: 6 months
Quality Adjusted Life Years (QALYs): quality of life
Time frame: 9 months
Quality Adjusted Life Years (QALYs): quality of life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Smelson, PsyD principal investigator
University of Massachusetts, Worcester
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication for Opioid Use Disorder, MISSION Critical Time Intervention and MISSION Peer Support in people with Opioid Use Disorder and Mental Health Disorder, run by University of Massachusetts, Worcester at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Smelson, PsyD (508-713-5420, David.Smelson@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in treatment (time frame: 6 months). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.