Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

September 12, 2026 updated by: Centre for Addiction and Mental Health

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder: A Human Laboratory Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants with alcohol use disorder will receive treatment daily (600mg cannabidiol or placebo), each for 10 consecutive days, with a 2-week long washout period between treatments. Participants will be randomized to receive placebo or cannabidiol first (in blocks of random size) so that equal number of participants are allocated to each sequence. Around day 8 of each treatment period, participants will complete an alcohol self-administration session in the laboratory to assess the effects of treatment on alcohol consumption and alcohol-related craving.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Able to communicate and provide informed consent in English.
  • Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST) level should not be more than 2 times the upper normal limit, and bilirubin should not be more than 1.5 times the upper normal limit.
  • Enrolled in the Ontario Health Insurance Plan (OHIP)
  • Willing and able to safely abstain from alcohol for at least 12 hours prior to the eligibility and alcohol self-administration visit.
  • Individuals who are capable of becoming pregnant: agree to the use of highly effective contraception during study participation and for an additional 28 days after the end of cannabidiol administration.

Exclusion Criteria:

  • 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
  • Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
  • Current medical conditions, prescriptions, or over the counter medications that interfere with receiving the study drug or alcohol (based on the study physician's assessment)
  • Severe mental illness (e.g. active psychosis with ongoing delusions and/or hallucinations, active manic or hypomanic episodes, evidence of a major neurocognitive disorder, etc.) and other substance use disorders (moderate or severe; excluding tobacco use disorder) as determined by the qualified investigator
  • Experiencing active suicidal ideation within the past 1 month and/or suicide attempt within the past 6 months
  • Recent recreational drug use (assessed via urine toxicology screen) other than alcohol and nicotine products
  • Current use of CBD products or use of CBD products within the past month.
  • History of hypersensitivity to CBD
  • Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)
  • Currently pregnant or breastfeeding or intending to become pregnant or breastfeed.
  • Currently institutionalized which refers to a person who lives in an institutional collective dwelling, such as a hospital, nursing home or prison, including a resident under custody (e.g., patient or inmate).
  • Currently in treatment for AUD (e.g. Alcoholics Anonymous, group therapy, individual therapy, on anticraving medication)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cannabidiol
10-day supply of 600 mg of CBD, taken orally twice daily
Drug: Oral solution
300 mg taken morning and evening
Placebo Comparator: Placebo
10-day supply of 600 mg of placebo, taken orally twice daily
Drug: Oral solution
300 mg taken morning and evening

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total number of drinks administered during the alcohol-self administration session
Time Frame: 2 hours
Number of drinks consumed during the alcohol self-administration session.
2 hours
Peak breath alcohol concentration during the alcohol-self administration session
Time Frame: 2 hours
Maximum breath alcohol concentration during the alcohol self-administration session.
2 hours
Craving at baseline as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.
Time Frame: Baseline
Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)
Baseline
Craving following the priming dose of alcohol as measured by the Alcohol Urge Questionnaire during the alcohol self-administration session.
Time Frame: 20 min after priming dose
Alcohol Urge Questionnaire Scores (minimum score = 8; maximum score = 56; higher scores indicates higher levels of craving)
20 min after priming dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale
Time Frame: 3 hours
Brief Biphasic Alcohol Effects Scale (stimulation factor ranges from 0-30, sedation factor ranges from 0-30)
3 hours
Differences in alcohol consumption (measured by the Timeline Follow Back method) outside of the lab during treatment with CBD vs. placebo
Time Frame: 10 days
Number of drinks, drinking days and binge drinking (≥ 4 drinks during a single day for females, ≥ 5 drinks during a single day for males)
10 days
Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo
Time Frame: 7 days
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving)
7 days
Differences in self-reported anxiety (measured by modified Generalized Anxiety Disorder-7) outside of the lab during treatment with CBD vs. placebo
Time Frame: 7 days
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
7 days
Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire.
Time Frame: 3 hours
Drug Effects Questionnaire (each item scored from 0 to 100). The higher the score, the more the participant feels that "effect".
3 hours
Safety and tolerability of CBD
Time Frame: Approximately 5 weeks
Measured through monitoring adverse effects during the study, measured by number of adverse effects and severity of adverse effect.
Approximately 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Sloan, MD, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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