NCT07148843

Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving

Not yet recruiting Phase 2/Phase 3 Last updated 30 April 2026

What this trial tests

Phase 2/Phase 3 trial testing Cannabidiol (CBD) in Alcohol Use Disorder (AUD) in 105 participants. Not yet recruiting.

Timeline

1 August 2026

Primary endpoint
1 October 2030

31 October 2030

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2/Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	105
Start date	1 August 2026
Primary completion	1 October 2030
Estimated completion	31 October 2030
Sites	1 location across United States

Drugs / interventions tested

• Cannabidiol (CBD) — full drug profile →
• Placebo

Conditions studied

• Alcohol Use Disorder (AUD) — all drugs for Alcohol Use Disorder (AUD) →
• Withdrawal From Addictive Substance; Detoxification — all drugs for Withdrawal From Addictive Substance; Detoxification →
• Craving — all drugs for Craving →

Sponsor

Johns Hopkins University

Who can join

Adults 21 to 65, any sex, with Alcohol Use Disorder (AUD) or Withdrawal From Addictive Substance; Detoxification. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 sens
• 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 i

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.