Clinical Trial

Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use

Study acronym: CALM
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 5 changes
notable Primary completion pushed: 2030-12-01 -> 2031-02-01 2026-06-12
minor Completion pushed: 2031-02-01 -> 2031-04-01 2026-06-12
notable Primary completion moved earlier: 2031-04-30 -> 2030-12-01 2026-05-07
minor Completion moved earlier: 2031-04-30 -> 2031-02-01 2026-05-07
critical Phase changed: Phase 2/3 -> Phase 2 2026-04-22
Trial Details
NCT Number NCT07527338
Lead Sponsor University of Colorado, Boulder
Conditions Sleep, Alcohol Misuse
Enrollment 58 participants
Start Date 2026-07-01
Primary Completion 2031-02-01 (estimated)
Study Completion 2031-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-11