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Cannabidiol for Alcohol Withdrawal and Craving

This study is looking at whether cannabidiol (CBD), a component of cannabis, can help people who are going through alcohol withdrawal and experiencing cravings. CBD has been shown to reduce anxiety, sleep problems, and seizures in people without alcohol use disorder (AUD), and these are common symptoms of alcohol withdrawal. In this study, adults aged 21-65 with moderate to severe AUD will stay at Johns Hopkins Hospital for 5 days and 4 nights. During this time, they will stop drinking alcohol and receive care for their withdrawal symptoms. Some participants will receive CBD, while others will receive a placebo (an inactive substance). Researchers will measure how well CBD helps with alcohol withdrawal symptoms using tools like the Alcohol Withdrawal Symptom Checklist (AWSC) and the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar), and also track sleep patterns. The study is currently unclear on its status and aims to enroll 105 participants.

Study design
This is an interventional study that will compare cannabidiol (CBD) to a placebo. It plans to enroll 105 participants.
What's involved
Participants will be admitted to an inpatient research unit for a 5-day, 4-night stay. During this time, alcohol withdrawal symptoms and sleep will be monitored four times daily.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored during their 4-night inpatient stay.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07148843

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Not Yet Recruiting
PHASE2Ages 21–65InterventionalTreatment
Johns Hopkins University
~105 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Cannabidiol (CBD)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)
Measured over Four times daily during inpatient stay (4 nights)
+3 more outcomes measured

Conditions

Alcohol Use Disorder (AUD)
Withdrawal From Addictive Substance; Detoxification
Craving

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • David Woliinsky, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

David Woliinsky, MD
[email protected]
(410) 550-0047
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)Four times daily during inpatient stay (4 nights)

    The Alcohol Withdrawal Symptom Checklist (AWSC) is a validated measure in which participants report their own withdrawal symptoms. The scale consists of 17 items. The total possible score is 0-68, with higher scores indicating more severe withdrawal symptoms. The highest score for a participant across the duration of their time on the Clinical Research Unit (CRU) will be included in the analysis.

  • Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)4 times daily during inpatient stay (4 nights)

    The Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) is a clinically administered measurement that represents the gold standard for assessing the severity of withdrawal symptoms. It consists of 10-items: nausea/ vomiting, tremor, paroxysmal sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation/clouding of sensorium. Each sign and symptom is rated on a Likert scale from 0-7 (with 0=absent and 7 =most severe), except for "clouding of sensorium," which is ranked from 0 to 4. Scores on the CIWA-Ar scale range from 0 to 67, with higher scores indicating more severe withdrawal. The highest score for a participant across the duration of their time on the CRU will be included in the analysis. Clinical staff will use these scores to justify administration of benzodiazepines to treat withdrawal symptoms.

  • Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy4 nights during inpatient stay

    Actigraphy will provide a primary assessment of sleep outcomes including total sleep time and wake after sleep onset. The actigraphy devices used will be triaxial accelerometers from GT0X Link Wrist Actigraphy, Actigraph LLC. Values for total sleep time and wake time after sleep onset will be averaged across the study's four nights; this average will be included in the analysis.

  • Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)Four times daily during inpatient stay (4 nights)

    The Alcohol Urge Questionnaire (AUQ) is an eight-item self-report questionnaire that has demonstrated validity and discriminative value in identifying and measuring alcohol craving. Each item is ranked on a score of 0 to 7, with a maximum score range of 0- 56. Higher scores indicate greater craving. The highest score for a participant across the duration of their time on the CRU will be included in the analysis.