Cannabidiol
300mg broad spectrum hemp extract in 50mg softgels
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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
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-11
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
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Interventions
300mg broad spectrum hemp extract in 50mg softgels
Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin
Eligibility
primary outcomes
Time frame: 4 weeks
Self reported sleep quality using the Patient Reported Outcomes Measurement Information Scale (PROMIS) Sleep Disturbance Subscale. The scale consists of eight items with a minimum score of eight and a maximum score of 40. Higher scores correspond to worse sleep quality.
Time frame: 4 weeks
Subjective report of alcohol craving using the Penn Alcohol Craving Scale. Scores range from 0 to 35, with higher scores corresponding to greater alcohol craving.
Time frame: 4 weeks
Measure of frequency of alcohol use using the Timeline Followback
Time frame: 4 weeks
A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch
Time frame: 4 weeks
An average of total time spent asleep each night as measured by a continuously worn actigraphy watch
Time frame: 4 weeks
Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography
secondary outcomes
Time frame: 4 weeks
Subjective report of symptoms of anxiety, depression, and stress using the Depression Anxiety Stress Scale (DASS). The DASS is a 21-item short-form measuring three related negative emotional states of depression, anxiety, and tension/stress. Scores for the entire measure range from 0 to 63, with higher scores corresponding to worse mood and stress outcomes. Subscales can also be scored individually (0-21).
other outcomes
Time frame: 4 weeks
Safety monitoring of alcohol withdrawal symptoms using the Combine Systematic Assessment for the Treatment of Emergent Effects
Time frame: 4 weeks
Safety monitoring of alcohol withdrawal symptoms using the Revised Clinical Institute Withdrawal Assessment of Alcohol Scale
Time frame: 4 weeks
Safety monitoring of risk for behaviors related to self-injury or suicide as measured by the Columbia Suicide Severity Rating Scale (C-SSRS). It includes five 'yes/no' items and follow-up interview items examining ideation intensity and characterization of suicidal behaviors. Research is mixed on whether a combined score (ideation and behavior) is meaningful on the C-SSRS. For the purposes of this study, any score greater than 0 is considered clinically significant. Suicidal ideation is defined by a scores of 'yes' on any items 1-5 and suicidal behavioral correspondents to 'yes' on any items 6-10.
Time frame: 4 weeks
Safety monitoring of liver functioning for as determined by levels of alanine transaminase (ALT) and aspartate transaminase (AST) in blood samples. The upper limit of normal functioning typical for both AST and ALT for men is 35-40 units per liter (U/L) and 25-30 U/L for women.
Publications
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