INTERVENTIONALNOT YET RECRUITINGNCT07148843

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-18

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2, PHASE3
Enrollment: 105 (ESTIMATED)
Start date: 2026-10-01
Sponsor: Johns Hopkins University
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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 admitted for medically supervised withdrawal including seizures and delirium tremens (the latter of which can be fatal if not managed appropriately) and can interfere with treatment efforts. Benzodiazepines, such as lorazepam (Ativan) represent the first-line treatments for control of alcohol withdrawal, yet higher doses of benzodiazepines required to manage more complicated withdrawal cases increase risk of respiratory depression and delirium. Furthermore, a growing frequency of benzodiazepine shortages (at least 20 shortages within the previous ten years lasting a median of 244 days) necessitates a need for alternative and adjunctive medications. Preclinical animal trials involving cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) have shown its use is associated with statistically significant reductions in withdrawal symptoms and there is evidence in non-AUD populations that CBD is effective in reducing anxiety, insomnia, and seizures, which are all symptoms of alcohol withdrawal. The capacity for CBD to enhance the effect of the inhibitory neurotransmitter GABA in a manner akin to benzodiazepines has also been demonstrated. Collectively this information suggests that CBD could alleviate signs and symptoms of alcohol withdrawal, and subsequently reduce the need for adjunctive benzodiazepines. This randomized placebo-controlled clinical trial will enroll adults with moderate-to-severe AUD who will be admitted to an inpatient research unit at the Johns Hopkins Hospital for management of their alcohol withdrawal. Enrolled participants with a history of alcohol withdrawal symptoms will be randomized to receive an oral formulation of either placebo or one of two CBD doses (10 mg/kg or 20 mg/kg). These doses have been well-studied and tolerated in prior studies and clinical trials for other disorders. Alcohol withdrawal symptoms, as defined by Diagnostic and Statistical Manual (DSM-5) criteria, will be assessed by nursing administration of the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) and participant completion of the Alcohol Withdrawal Symptom Checklist (AWSC). The CIWA-Ar scale will be used to guide the administration of symptom-triggered lorazepam (trade name Ativan) for all participants. As insomnia is a DSM-5 criterion for alcohol withdrawal, sleep quality will be assessed by completion of the Consensus Sleep Diary (CSD) and wrist actigraphy. Last, since cravings correlate closely with withdrawal symptoms and CBD has been observed to reduce craving for other substances, we will explore CBD's impact on alcohol craving by having participants complete the Alcohol Urge Questionnaire throughout the study. In short, the goals of this study will be to (1) determine the effect of CBD on physiologic and subjective symptoms of alcohol withdrawal, (2) determine the capacity of CBD to improve insomnia and disordered sleep during withdrawal, and (3) determine if CBD can attenuate alcohol cravings during acute abstinence. Results from this study can help inform the possible use of CBD as a novel adjunct treatment for alcohol withdrawal and cravings that may reduce benzodiazepine need for alcohol withdrawal treatment. If CBD is shown to be effective, this line of work also points to the potential of the endogenous cannabinoid system playing a mechanistic role in alcohol's withdrawal symptoms. Finally, this study could provide further insights into the efficacy of CBD as a sleep agent for participants with alcohol withdrawal and lay the groundwork for subsequent studies exploring CBD's use in the treatment of alcohol withdrawal in an outpatient setting.

Population and criteria

Sex

ALL

Minimum age

21 Years

Maximum age

65 Years

Healthy volunteers

Not accepted

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

primary 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 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)

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.

secondary measures