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New treatment option for Alcohol Use Disorder
Official title Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06512389
What this study is testing
What is Oral solution?
Oral solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.