Health TrialsbyHealthPanel

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCentre for Addiction and Mental Health

About this trial

This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets DSM-5 criteria for AUD.

Meets drinking criteria of average weekly consumption > 10 standard drinks for women and > 15 standard drinks for men over the past 90 days.

Willing to take study medication and participate in laboratory sessions requiring self-administration of alcohol

Agrees not to use cannabis or illicit drugs during the study period.

Disqualifiers

Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initial assessment

History of severe alcohol withdrawal including withdrawal seizures, alcoholic hallucinosis, or delirium tremens

Any history of seizures

Serious unstable medical condition, including severe hepatic abnormalities

Trial design

Design model

Crossover

Treatments tested in this trial

  • Oral solution

    Drug

    300 mg taken morning and evening

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: CannabidiolExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total number of drinks administered during the alcohol-self administration session

Number of drinks consumed during the alcohol self-administration session.

Time frame
2 hours
2

Peak breath alcohol concentration during the alcohol-self administration session

Maximum breath alcohol concentration during the alcohol self-administration session.

Time frame
2 hours
3

Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.

Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)

Time frame
Baseline
4

Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.

Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)

Time frame
20 min after priming dose

Secondary outcomes

1

Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire.

Drug Effects Questionnaire (each item scored from 0 to 100). The higher the score, the more the participant feels that "effect".

Time frame
3 hours
2

Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale

Brief Biphasic Alcohol Effects Scale (stimulation factor ranges from 0-30, sedation factor ranges from 0-30)

Time frame
3 hours
3

Safety and tolerability of CBD

Measured through monitoring adverse effects during the study, measured by number of adverse effects and severity of adverse effect.

Time frame
Approximately 5 weeks
4

Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo

Number of drinks, drinking days and binge drinking (≥ 4 drinks during a single day for females, ≥ 5 drinks during a single day for males)

Time frame
10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre for Addiction and Mental Health

Lead sponsor

Source ClinicalTrials.gov
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