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Supporting Treatment Access and Recovery in COD

Study acronym: STAR-COD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
See other at-risk trials from University of Massachusetts, Worcester

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 10 of 11 entries
    • Study description revised
  2. Re-verified, no change to tracked fieldsv11
  3. Primary and study completion dates: Aug 2026 to Aug 31, 2026v10
  4. Primary completion date: Jun 1, 2025 to Aug 2026v9 Show 4 more changesShow less
    • Primary endpoints: 68 to 58
    • Study completion date: Aug 31, 2025 to Aug 2026
    • Secondary endpoints: 1 to 11
    • Study description shortened, about 4 words
  5. Primary completion date: Dec 31, 2024 to Jun 1, 2025v8
Show 6 earlier versionsHide 6 earlier versions
  1. Collaborators revised (4)v7
  2. Study sites: 13 to 5v6
  3. Study sites: 9 to 13
    • Collaborators: 3 to 4
    • Study description expanded, about 1 word
    v5
  4. Primary completion date: Dec 2024 to Dec 31, 2024
    • Study completion date: Dec 2024 to Aug 31, 2025
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Mar 11, 2022
    • Site details revised at 9 of 9 sites
    v3
  6. Start date: Dec 2021 to Feb 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number 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)
Conditions
(from sponsor)		 Opioid Use Disorder, Mental Health Disorder
Related terms Mental Disorders, Opioid-Related Disorders, Psychological Well-Being
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov