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Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

Study acronym: DEMURE
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Start date: May 2026 to Oct 2026
    • Primary and study completion pushed from Dec 2027 to May 2028
    v5
  2. Start date: Jan 2026 to May 2026
    • Primary and study completion dates: Aug 2027 to Dec 2027
    v4
  3. Start date: Sep 2025 to Jan 2026
    • Primary and study completion dates: Apr 2027 to Aug 2027
    • Collaborators expanded, about 6 words
    v3
  4. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 10 entries
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \[THC\]) and Epidiolex (cannabidiol \[CBD\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.
Trial Details
NCT Number NCT07148206
Lead Sponsor Montefiore Medical Center
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov