Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification, Craving

In brief

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.

Key facts

Study ID

NCT07148843

Run by

Johns Hopkins University

People needed

105

Starts

2026-08-01

Expected to finish

2030-10-31

Last updated by the study team

2026-07-10

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 interfere with participant safety as determined by study physician.
• Current pregnancy
• BMI <17
• History of anorexia nervosa or bulimia in the past 2 years
• History of seizures or seizure disorder outside of alcohol-withdrawal related seizures
• Systolic blood pressure (SBP) > 180, Diastolic Blood Pressure (DBP) > 120 or pulse > 120 during screening or upon admission
• Any of the following laboratory values during screening or upon admission:
• AST > 165 U/L (normal range 19-55)
• ALT > 216 U/L (normal range 19-72)
• Alkaline phosphatase > 378 U/L (normal range 38-126)
• Total bilirubin >2.5 mg/dl (normal values=0.3-1.0 mg/dL)
• Non-fasting glucose > 250 mg/ml (normal range 65-179)
• Hematocrit < 38 % (normal range 41-53)
• Hemoglobin < 12 g/dl (normal range 13.5-17.5) or any other laboratory value significantly outside the normal range
• Use of a prescription medication (except for birth control prescriptions) within 14 days of study entry, which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication in which CYP2C9, CYP2C19, CYP1A2, CYP2B10, or CYP3A4 enzymes are major metabolizers.
• ECG with corrected QT interval (QTC) >/= 500 ms and/or presence of clinically significant abnormality
• Participation in other clinical trials within the past 60 days
• Court-mandated participation in alcohol treatment or pending incarceration

Where it is running

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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