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Cannabinoid
Cannabidiol for Alcoholism
Phase 2
Recruiting
Led By Matthew Sloan, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to communicate and provide informed consent in English
Willing to take study medication and participate in laboratory sessions requiring self-administration of alcohol
Must not have
Serious unstable medical condition, including severe hepatic abnormalities
Current use of CBD products or use of CBD products within the past month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 min after priming dose
Summary
This trial will investigate how cannabidiol affects alcohol consumption and cravings in people with alcohol use disorder. Participants will receive both cannabidiol and a placebo in a controlled study to see the difference
Who is the study for?
This trial is for individuals with alcohol use disorder who are interested in testing a new treatment. Participants must meet certain health criteria to join, but specific inclusion and exclusion details were not provided.
What is being tested?
The study is testing the effects of an oral solution of cannabidiol (CBD) on reducing alcohol craving and consumption compared to a placebo. It's set up so each participant will try both CBD and the placebo at different times, with a break in between.
What are the potential side effects?
Potential side effects are not detailed here, but common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight. Each person's experience could vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can communicate and understand information in English.
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I am willing to take the study medication and drink alcohol as part of the study.
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I have been drinking more than the recommended amount weekly for the past 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any severe liver problems or other serious unstable conditions.
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I have used CBD products recently.
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I have had thoughts of harming myself or attempted suicide recently.
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I have a history of seizures.
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I experience intense flushing after drinking 1-2 alcoholic beverages.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.
Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.
Peak breath alcohol concentration during the alcohol-self administration session
+1 moreSecondary study objectives
Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo
Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo
Differences in self-reported anxiety (measured by modified Generalized Anxiety Disorder-7) outside of the lab during treatment with CBD vs. placebo
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CannabidiolExperimental Treatment1 Intervention
10-day supply of 600 mg of CBD, taken orally twice daily
Group II: PlaceboPlacebo Group1 Intervention
10-day supply of 600 mg of placebo, taken orally twice daily
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,851 Total Patients Enrolled
20 Trials studying Alcoholism
3,717 Patients Enrolled for Alcoholism
Matthew Sloan, MDPrincipal InvestigatorCentre for Addiction and Mental Health
2 Previous Clinical Trials
463 Total Patients Enrolled
2 Trials studying Alcoholism
463 Patients Enrolled for Alcoholism