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NCT07527338
Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use
Conditions: Sleep, Alcohol Misuse
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 58
Sponsor: University of Colorado, Boulder
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
Eligibility Criteria
Inclusion Criteria:
* 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)
* For female participants of childbearing potential: Not pregnant or lactating at the time of study enrollment or trying to become pregnant as confirmed by urine preg. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
* For female participants of childbearing potential: Agree to use a highly effective contraception method (i.e., a method with a failure rate of less than 1 percent per year when used consistently and correctly) starting at least five days before you begin the study and continuing for full participation.
* No current use of sleep medications including CBD in the last 90 days
* No history of complicated alcohol withdrawal (i.e., seizure, delirium tremens, or alcohol hallucinosis).
* No current or past 6 months active suicidal ideation or suicidal behavior
* No current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
* No current cannabis use disorder (MINI SUD for cannabis score ≧2)
* History of previous exposure to guaiol through CBD or other cannabis product
Exclusion Criteria:
* Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
* Greater than low risk for obstructive sleep apnea (STOP-BANG \
Source: ClinicalTrials.gov (NCT07527338). StuddyBuddy aggregates publicly available trial information.