Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2022-03-11
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Full MISSION
CTI + DRT + PS + MOUD
Medication for Opioid Use Disorder
medication management
MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
CTI & DRT
CTI + DRT + MOUD
Medication for Opioid Use Disorder
medication management
MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
CTI & PS
CTI + PS + MOUD
Medication for Opioid Use Disorder
medication management
MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
DRT & PS
DRT + PS + MOUD
Medication for Opioid Use Disorder
medication management
MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
MOUD only
MOUD
Medication for Opioid Use Disorder
medication management
Interventions
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Medication for Opioid Use Disorder
medication management
MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Massachusetts, Lowell
OTHER
Cornell University
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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David Smelson
Professor
Principal Investigators
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David Smelson, PsyD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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Behavioral Health Network
Holyoke, Massachusetts, United States
Behavioral Health Network
Orange, Massachusetts, United States
Behavioral Health Network
Springfield, Massachusetts, United States
UMass Chan Road to Care Clinic
Worcester, Massachusetts, United States
SaVida Health
Worcester, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Herschelle Reaves
Role: primary
Other Identifiers
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H00023911
Identifier Type: -
Identifier Source: org_study_id
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