Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder

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

Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder (NCT06512389) is a Phase 2 interventional studying Alcohol Use Disorder, sponsored by Centre for Addiction and Mental Health. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Alcohol Use Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

Oral solution

300 mg taken morning and evening

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06512389), the sponsor (Centre for Addiction and Mental Health), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06512389 clinical trial studying?

Who can participate in NCT06512389?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06512389?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06512389. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06512389. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.