Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

NCT07148843 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00519608
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

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

Keywords

alcohol abstinence; alcohol withdrawal treatment; detoxification

Outcome Measures

Primary Outcomes (4)

• Peak score on the Alcohol Withdrawal Symptom Checklist (AWSC)

  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.

  Four times daily during inpatient stay (4 nights)

• Peak score on the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar)

  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.

  4 times daily during inpatient stay (4 nights)

• Average total sleep time (minutes) and wake after sleep onset as measured by wrist actigraphy

  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.

  4 nights during inpatient stay

• Peak alcohol craving as measured by scores on the Alcohol Urge Questionnaire (AUQ)

  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.

  Four times daily during inpatient stay (4 nights)

Secondary Outcomes (8)

• Average Total Sleep Time (minutes) as reported in Consensus Sleep Diary (CSD) results

  Upon waking each morning during inpatient stay (4 days)

• Total Amount of Time (minutes) on Awakenings, as reported in Consensus Sleep Diary (CSD) results

  Upon waking each morning during inpatient stay (4 days)

• Sleep Quality as reported in Consensus Sleep Diary (CSD) results

  Upon waking each morning during inpatient stay (4 days)

• Sleep Latency (minutes) as reported in Consensus Sleep Diary (CSD) results

  Upon waking each morning during inpatient stay (4 days)

• Number of Awakenings as reported in Consensus Sleep Diary (CSD) results

  Upon waking each morning during inpatient stay (4 days)

Study Arms (3)

10 mg/kg CBD

ACTIVE COMPARATOR

low dose CBD

Drug: Cannabidiol (CBD)

20 mg/kg CBD

ACTIVE COMPARATOR

high dose CBD

Drug: Cannabidiol (CBD)

placebo

PLACEBO COMPARATOR

Placebo (no CBD)

Drug: Placebo

Interventions

Cannabidiol (CBD) DRUG

Cannabidiol

10 mg/kg CBD; 20 mg/kg CBD

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Abstinence

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• David Woliinsky, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Woliinsky, MD

CONTACT

(410) 550-0047; dwolins2@jhmi.edu

Elise M Weerts, PhD

CONTACT

410-550-2781; eweerts@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the study team, CRU medical staff, and statistician assessing outcomes will be blinded to the study. The pharmacists will randomize subjects to study arms and if needed can reveal intervention if needed (e.g., clinical care).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 29, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)