Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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.
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.
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 (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
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol (CBD)
DrugCannabidiol
Placebo
Drugplacebo
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: 10 mg/kg CBDActive comparator 1 intervention
Group B: 20 mg/kg CBDActive comparator 1 intervention
Group C: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Four times daily during inpatient stay (4 nights)2
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.
Time frame
4 times daily during inpatient stay (4 nights)3
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 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.
Time frame
4 nights during inpatient stay4
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.
Time frame
Four times daily during inpatient stay (4 nights)Secondary outcomes
1
Average Total Sleep Time (minutes) as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure in which participants rate features of their sleep-average total sleep time. Generally higher number is better.
Time frame
Upon waking each morning during inpatient stay (4 days)2
Total Amount of Time (minutes) on Awakenings, as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure in which participants rate features of their sleep- total amount of time on awakenings. Higher number indicating more awakenings (worse).
Time frame
Upon waking each morning during inpatient stay (4 days)3
Sleep Quality as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep--sleep quality either "Very Poor," "Poor," "Fair," "Good," or "Very Good"
Time frame
Upon waking each morning during inpatient stay (4 days)4
Sleep Latency (minutes) as reported in Consensus Sleep Diary (CSD) results
The Consensus Sleep Diary (CSD) is a standardized subjective sleep rating measure consisting of nine items in which participants rate features of their sleep - sleep latency (how long it takes one to fall asleep). Higher values would indicate worse sleep latency.
Time frame
Upon waking each morning during inpatient stay (4 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov