Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
NCT07527338 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2026-05-08
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
Conditions
- Sleep
- Alcohol Misuse
Interventions
- DRUG
-
Cannabidiol
300mg broad spectrum hemp extract in 50mg softgels
- DRUG
-
Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin
Sponsors & Collaborators
-
University of Colorado, Boulder
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2030-12-01
- Completion
- 2031-02-01
- FDA Drug
- Yes
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