Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Colorado, Boulder
About this trial
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
Eligibility criteria
Qualifiers
Able to provide informed consent
Self reported poor sleep quality (PSQI score >5)
Hazardous or harmful levels of alcohol consumption (MINI AUD score ≧2)
No current moderate or severe alcohol withdrawal symptoms (CIWA-Ar)
Disqualifiers
Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
Greater than low risk for obstructive sleep apnea (STOP-BANG <=4 or Moderate or greater risk as calculated by Nox Noxturnal Software from baseline PSG data)
Current use of medications known to have major interactions with Epidiolex (e.g., brexanolone, buprenorphine, colchicine, esketamine, fezolinetant, ketamine, leflunomide, levoketoconazole, levomethadyl acetate, lomitapide, mipomersen, morphine, pexidartinib, pralsetinib, propoxyphene, relugolix, sodium oxybate, teriflunomide, and venetoclax)
Current use of anti-psychotic medications
Trial design
Treatments tested in this trial
- Cannabidiol
- Placebo
Treatment groups
58 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov