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Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

Study acronym: COMBO
StatusRecruiting
PhasePhase 2/3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jun 1, 2026 to Jan 1, 2027
    • Site details revised at 1 of 2 sites
    v12
  2. Re-verified, no change to tracked fieldsv11
  3. Site contacts updated at 1 of 2 sites
    • Collaborator revised
    v10
  4. Start date: Aug 1, 2022 to Apr 18, 2023
    • Eligibility criteria revised
    • Site contacts updated at 1 of 2 sites
    • Collaborator revised
    v9
  5. Site details revised at 1 of 2 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 1 to 2
    • Eligibility criteria expanded, about 86 words
    v7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  3. Start date: May 1, 2022 to Aug 1, 2022v5
  4. Primary endpoint revised
    • Eligibility criteria expanded, about 31 words
    v4
  5. Start date: Mar 1, 2022 to May 1, 2022v3
  6. Start date: Oct 1, 2021 to Mar 1, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.
Trial Details
NCT Number NCT05011266
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid-use Disorder
Related terms Opioid-Related Disorders
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov