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Adjunctive Cannabidiol for Recovery From Opioid Study

Study acronym: ACROS
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 15 entries
    • Site contacts updated at 1 of 2 sites
  2. Study sites: 1 to 2v4
  3. Primary completion date: May 1, 2028 to Jul 15, 2027
    • Study completion date: May 1, 2028 to Aug 15, 2027
    • Site contact updated
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2025 to Jun 13, 2025
    • Study description expanded, about 363 words
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.
Trial Details
NCT Number NCT06940674
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute on Drug Abuse (NIDA), International Center for Health Outcomes and Innovation Research, Brains Bioceutical
Conditions
(from sponsor)		 Opioid Use Disorder (OUD)
Related terms Opioid-Related Disorders
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov