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Supporting Treatment Access and Recovery in COD

NCT05138614 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-06-05

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Massachusetts, Lowell

    collaborator OTHER

  • Cornell University

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • David Smelson, PsyD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138614 on ClinicalTrials.gov