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Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use

Study acronym: CALM
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: May 31, 2026 to Jul 1, 2026
    • Primary completion pushed from Dec 1, 2030 to Feb 1, 2031
    • Study completion pushed from Feb 1, 2031 to Apr 1, 2031
    v6
  2. Start date: May 1, 2026 to May 31, 2026
    • Primary completion moved earlier from Apr 30, 2031 to Dec 1, 2030
    • Study completion moved earlier from Apr 30, 2031 to Feb 1, 2031
    v5
  3. Primary completion date: Apr 30, 2031 to Dec 1, 2030
    • Study completion date: Apr 30, 2031 to Feb 1, 2031
    v4
  4. Phase changed: Phase 2/3 → Phase 2v3
  5. Secondary endpoints: details revised at 1 of 1 entryv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are: Does 4 weeks of nightly cannabdiol use: 1. improve sleep quality and time spent in REM sleep? 2. decrease alcohol use and alcohol craving? 3. pose any safety risks? Researchers will compare cannabidiol to a placebo (a look-alike substance that contains no drug). Participants will: Take cannabidiol every night for 4 weeks Visit the clinic once at the beginning and once at the end of the study Wear an activity monitoring watch while in the study Complete an at-home sleep test both at the beginning and the end of the study Check in once a week with researchers via video conference
Trial Details
NCT Number NCT07527338
Lead Sponsor University of Colorado, Boulder
Conditions
(from sponsor)		 Sleep, Alcohol Misuse
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov