Status:
NOT_YET_RECRUITING
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder (AUD)
Withdrawal From Addictive Substance; Detoxification
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
PHASE3
Brief 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 (AU...
Detailed Description
Alcohol withdrawal during acute abstinence represents a major health threat to millions of individuals struggling with alcohol use disorder (AUD): it has been associated with complications in patients...
Eligibility Criteria
Inclusion
- 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 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
Exclusion
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2030
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT07148843
Start Date
January 15 2026
End Date
October 31 2030
Last Update
November 13 2025
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224