A Phase 2 interventional study of Cannabidiol and Placebo in Sleep and Alcohol Misuse, sponsored by University of Colorado, Boulder. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Colorado, Boulder · Phase 2, Interventional, and Treatment
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:
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
University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cannabidiol
Drug: Placebo
300mg broad spectrum hemp extract in 50mg softgels
Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin
Subjective Sleep Quality
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
Alcohol Craving
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
Alcohol Use Frequency
Measure of frequency of alcohol use using the Timeline Followback
Time frame: 4 weeks
Sleep Efficiency
A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch
Time frame: 4 weeks
Total Sleep Time
An average of total time spent asleep each night as measured by a continuously worn actigraphy watch
Time frame: 4 weeks
Time Spent in REM
Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography
Time frame: 4 weeks
Mood and Stress
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).
Time frame: 4 weeks
Alcohol Withdrawal
Safety monitoring of alcohol withdrawal symptoms using the Combine Systematic Assessment for the Treatment of Emergent Effects
Time frame: 4 weeks
Alcohol Withdrawal
Safety monitoring of alcohol withdrawal symptoms using the Revised Clinical Institute Withdrawal Assessment of Alcohol Scale
Time frame: 4 weeks
Risk for Self-Injurious Behaviors
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
Blood levels of alanine transaminase and aspartate transaminase
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.
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol
University of Colorado, Boulder