Alcohol Use DisorderPhase 2NCT06512389
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
A Phase 2 study testing Oral solution in people with Alcohol Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Oral solution
- Keywords
- alcohol use disorder, cannabidiol, alcohol consumption, craving
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral solutionDrug
300 mg taken morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | 10-day supply of 600 mg of CBD, taken orally twice daily Receives: Drug: Oral solution |
| Placebo | Placebo comparator | 10-day supply of 600 mg of placebo, taken orally twice daily Receives: Drug: Oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of drinks administered during the alcohol-self administration session
Number of drinks consumed during the alcohol self-administration session.
Measured: 2 hours
Peak breath alcohol concentration during the alcohol-self administration session
Maximum breath alcohol concentration during the alcohol self-administration session.
Measured: 2 hours
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)
Measured: Baseline
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)
Measured: 20 min after priming dose
Secondary outcomes (6)
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".
Measured: 3 hours
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)
Measured: 3 hours
Safety and tolerability of CBD
Measured through monitoring adverse effects during the study, measured by number of adverse effects and severity of adverse effect.
Measured: Approximately 5 weeks
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)
Measured: 10 days
Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving)
Measured: 7 days
Differences in self-reported anxiety (measured by modified Generalized Anxiety Disorder-7) outside of the lab during treatment with CBD vs. placebo
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start16 Aug 2024
- Primary completion20 Aug 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject randomized double-blind placebo controlled crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Sloan, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512389
- Sponsor's protocol ID
- 2021/102
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder: A Human Laboratory Study
- ClinicalTrials.gov ID
- NCT06512389
- Acronym / sponsor ID
- 2021/102
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol use disorder, cannabidiol, alcohol consumption, craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject randomized double-blind placebo controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Oral solution10-day supply of 600 mg of CBD, taken orally twice daily |
| Placebo | Placebo comparator | Drug: Oral solution10-day supply of 600 mg of placebo, taken orally twice daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral solution300 mg taken morning and evening | Drug | Cannabidiol, Placebo |
Primary outcome
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.
Peak breath alcohol concentration during the alcohol-self administration session
Time frame: 2 hours
Maximum breath alcohol concentration during the alcohol self-administration session.
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)
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)
6 secondary outcomes
Subjective effects of alcohol during the alcohol self-administration session as measured by the Drug Effects Questionnaire.
Time frame: 3 hours
Subjective effects of alcohol during the alcohol self-administration session as measured by the Brief Biphasic Alcohol Effects Scale
Time frame: 3 hours
Safety and tolerability of CBD
Time frame: Approximately 5 weeks
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
Differences in alcohol craving (measured by Penn Alcohol Craving Scale) outside of the lab during treatment with CBD vs. placebo
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Sloan, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral solution in people with Alcohol Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of drinks administered during the alcohol-self administration session (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.