NCT07148843 · Johns Hopkins University
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Cannabidiol (CBD)
Cannabidiol
DRUG
Placebo
placebo
Primary outcome measures
Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)
Time frame: 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)
Time frame: 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 actigraphy
Time frame: 4 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 Generation model 9 (GT9X) 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder
- 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.
- Report at least 21 days of heavy drinking (four or more drinks for women, five or more drinks for men) over the last 28 days.
- if female of childbearing potential who has not had a sterilization procedure:
- Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen
- Agree to use a highly effective method of contraception (e.g. hormonal contraception, intrauterine device, double-barrier method) for at least five days prior to administration of the study drug and throughout the duration of the study
- 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 (i.e. twice a week or more) of CBD-dominant products, including Epidiolex®, within the last three months
- 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 moderate-to-severe Cannabis Use Disorder (except for alcohol- and tobacco-related disorders)
- •Urine drug screen indicating the presence of substances other than cannabis at screening.
- Active suicidal ideation or recent suicide attempts (e.g. within six months)
- Unstable and/or compromising medical or psychiatric conditions that would interfere with participant safety as determined by study physician.
- Current pregnancy
- BMI \<18.5 kg/m2
- History of anorexia nervosa or bulimia in the past 2 years
- History of seizures or seizure disorder outside of alcohol-withdrawal related seizures
- History of complicated alcohol withdrawal (e.g. seizures, delirium tremens) as verified by medical record review if available
- Mean systolic blood pressure (SBP) \>/= 140 mm Hg, DBP \>/= 90 mmHg or pulse \>/= 110 mm Hg during screening
- Mean systolic blood pressure (SBP) \>/=160 mm Hg, DBP\>/=110 mm Hg, or pulse \>/=120 mm Hg during pre-admission at Behavioral Pharmacology Research Unit (BPRU) prior to admission to CRU
- 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 \> 1.5x upper limit of normal (ULN) (normal range 38-126)
- Total bilirubin \>1.5 ULN (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. Participants taking medications that are substrates of UDP-glucuronosyltransferase 1-9 (UGT1A9), UDP-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and/or P-gp wll be allowed into the study but closely monitored for potential adverse events based on the prescribing information of the concomitant medications given CBD's potential to inhibit these enzymes.
- Use of prescription medications, OTC medications, herbal medications, and/or dietary supplements that are strong inducers of CYP3A4 or CYP2C19 within 14 days or 5 half-lives (whichever is longer) prior to study drug administration
- ECG with QT-corrected interval (QTc) \> 450 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.
- Known chronic liver disease or cirrhosis of any etiology (e.g. autoimmune, infections, Metabolic Dysfunction-Associated Steatohepatitis \[MASH\]\]) except in the following cases: 1. Fully resolved hepatitis B infection (HBsAg negative, anti-Hepatitis C core antibody (anti-HBc) and/or anti-Hepatitis B surface antibody (anti-HBs) positive, with normal liver function tests) or 2. Successfully treated hepatitis C infection (HCV RNA negative, with normal liver function tests and no evidence of advanced fibrosis or cirrhosis)
- Recent acute hepatitis of any etiology (e.g. drug-induced hepatitis, hepatitis A infection within the past six months)
- Moderate to severe hepatic impairment (Child-Pugh Class B and C)
Where
- Baltimore, Maryland
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations