Not Yet RecruitingPhase 2/3

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

United States105 participantsStarted 2026-08-01

Plain-language summary

Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder * Age 21-65 * Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning (i.e., unable to attend work or engage in typical activities) AND/OR required medications to manage symptoms. * Drinking at least 8 drinks a day over the two weeks prior to screening. * Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen * Shipley vocabulary score \> 18, corresponding to 5th grade reading level. * Demonstrated understanding of informed consent and ability to consent to participation in the study. Exclusion Criteria * Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe gastritis, hemoptysis, hematochezia, or melena. * Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission * Regular use (e.g., more than twice a week) of cannabis or CBD products. * Regular use of benzodiazepines (e.g., twice a week or more) within the last three months * Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including Cannabis Use Disorder (except for alcohol and tobacco) * Urine drug screen indicating the presence of substances other than cannabis at screening. * Unstable and/or compromising medical or psychiatric conditions that would interfer…

What they're measuring

Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)

Timeframe: Four times daily during inpatient stay (4 nights)

Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)

Timeframe: 4 times daily during inpatient stay (4 nights)

Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy

Timeframe: 4 nights during inpatient stay

Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)

Timeframe: Four times daily during inpatient stay (4 nights)

Trial details

NCT IDNCT07148843

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10

Contact for this trial

David Woliinsky, MD

(410) 550-0047 dwolins2@jhmi.edu

View on ClinicalTrials.gov More Alcohol Use Disorder (AUD) trials

Plain-language summary

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)

Timeframe: Four times daily during inpatient stay (4 nights)

Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)

Timeframe: 4 times daily during inpatient stay (4 nights)

Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy

Timeframe: 4 nights during inpatient stay

Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)

Timeframe: Four times daily during inpatient stay (4 nights)