Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use

NCT07527338 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-0483
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.improve sleep quality and time spent in REM sleep?
2. 2.decrease alcohol use and alcohol craving?
3. 3.pose any safety risks?

Conditions

Sleep; Alcohol Misuse

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  4 weeks

• Alcohol Use Frequency

  Measure of frequency of alcohol use using the Timeline Followback

  4 weeks

• Sleep Efficiency

  A calculation of objective quality of sleep as measured by a continuously worn actigraphy watch

  4 weeks

• Total Sleep Time

  An average of total time spent asleep each night as measured by a continuously worn actigraphy watch

  4 weeks

• Time Spent in REM

  Amount of time spent in the rapid eye movement sleep stage as measured by polysomnography

  4 weeks

Secondary Outcomes (1)

• Mood and Stress

  4 weeks

Other Outcomes (4)

• Alcohol Withdrawal

  4 weeks

• Alcohol Withdrawal

  4 weeks

• Risk for Self-Injurious Behaviors

  4 weeks

Study Arms (2)

300mg oral cannabidiol

EXPERIMENTAL

Drug: Cannabidiol

Placebo

SHAM COMPARATOR

Drug: Placebo

Interventions

Cannabidiol DRUG

300mg broad spectrum hemp extract in 50mg softgels

300mg oral cannabidiol

Placebo DRUG

Taste and appearance matched softgel with hemp seed oil, glycerin, and gelatin

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
• History of hypersensitivity reactions to cannabidiol
• Liver function test (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits at baseline
• Moderate or severe liver disease
• Allergy or aversion to gelatin (softgels contain porcine gelatin)
• Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days or positive screening on urine toxicology test at Baseline visit.
• Uncontrolled hypertension
• Blood pressure findings concerning for moderate or severe alcohol withdrawal at baseline
• Abnormal resting heart rate, defined as \<60 bpm or \>100 bpm at baseline

Sponsors & Collaborators

• University of Colorado, Boulder: lead

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ellie Sundali

CONTACT

720-378-8532; CALM.custudy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): April 30, 2031
• Last Updated: April 16, 2026

Record last verified: 2026-04