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Trial of Cannabidiol for the treatment of alcohol dependence
EU CTIS ID: 2023-504439-42-01
What this study is testing
Determine the change in the Timeline Follow-back (TLFB) assessment of alcohol consumption and the change in percent Carbohydrate Deficient Transferrin (CDT) in serum, to evaluate the therapeutic potential of CBD in the management of patients with alcohol dependence who are seeking treatment to achieve abstinence.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females aged 18-65
- DSM-5 diagnosis of moderate or severe AUD.
- Able to provide voluntary informed consent.
- At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen.
- If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.
- Able to provide at least two locators.
You likely can't join if
- Current alcohol withdrawal (CIWA-Ar score >7).
- Pregnancy or lactation.
- Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6.
- Allergy to any ingredient of the study compound.
- Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.
- No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.
See the full eligibility criteria
- Males and females aged 18-65
- DSM-5 diagnosis of moderate or severe AUD.
- Able to provide voluntary informed consent.
- At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen.
- If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial.
- Able to provide at least two locators.
- Endorse desire to cut down or stop drinking.
- Endorse desire to cut down or stop drinking.
- Current alcohol withdrawal (CIWA-Ar score >7).
- Pregnancy or lactation.
- Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6.
- Allergy to any ingredient of the study compound.
- Current treatment for AUD, with exception of AA/12-step treatment/mutual-help groups-.
- No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays.
- A positive urine drug screen for THC, cocaine and/or opioids at screen.
- Exclusionary medical conditions (e.g., current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function).
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder.
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
- Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidally.
- History of severe Traumatic Brain Injury (LOC > 24 hours).
- DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe substance use disorder for a substance other than alcohol or nicotine.
- Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel.
- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.