Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-65
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cannabidiol (CBD)
- Placebo
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov