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Study of Cannabidiol compared to placebo to treat alcohol dependence in adults seeking treatment to achieve abstinence

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying alcohol dependence and its treatment using Cannabidiol (CBD), which is administered as an oral solution. The study aims to determine if CBD can help people who want to reduce or stop their alcohol consumption.

During the trial, participants will receive either CBD oral solution or a placebo. The medication will be taken by mouth for a period of 8 weeks. The maximum daily dose of CBD that participants may receive is 600 mg, while the total maximum dose throughout the study period is 33,600 mg.

The study will evaluate how CBD affects drinking behavior and measure certain biological markers in the blood that indicate alcohol use. The research will also assess how well participants tolerate the medication and examine its overall safety for people with alcohol dependence. Additionally, the study will look at psychological aspects related to alcohol consumption and investigate how CBD interacts with the body's natural endocannabinoid system.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either cannabidiol oral solution or a placebo (a substance that looks identical but contains no active ingredient)

    The medication will be taken by mouth according to the prescribed schedule

    This phase focuses on evaluating how the treatment affects your alcohol consumption patterns

  2. Step 2

    Monitoring alcohol consumption

    Your alcohol consumption will be tracked using a method called Timeline Follow-back (TLFB), which helps record daily drinking patterns

    Blood tests will be conducted to measure Carbohydrate Deficient Transferrin (CDT), a substance in your blood that indicates alcohol consumption levels

  3. Step 3

    Regular assessments

    Your psychological symptoms related to alcohol consumption will be evaluated periodically

    Medical staff will monitor your overall health and any effects of the treatment

    Regular blood samples will be collected to evaluate your body's response to the treatment

  4. Step 4

    Safety monitoring

    Throughout the study, your tolerance to the medication will be carefully monitored

    Any side effects or safety concerns will be documented and addressed

    The study will continue until October 2028

Who can join the trial?

7 criteria

  • You must be between 18 and 65 years old
  • You must be diagnosed with moderate or severe Alcohol Use Disorder (AUD) according to medical diagnostic criteria
  • You must be able to understand and voluntarily agree to participate in the study
  • You must have had at least 8 heavy drinking days in the past 30 days before screening: - For women: 4 or more drinks per day - For men: 5 or more drinks per day
  • If you can have children (both men and women), you must agree to use approved birth control methods throughout the study
  • You must be able to provide at least two contact persons who can help locate you during the study
  • You must have a desire to reduce or stop drinking alcohol

Who cannot join the trial?

14 criteria

  • Persons under 18 years of age
  • Pregnant or breastfeeding women
  • People with severe liver disease (as it may affect how the medication is processed)
  • Individuals currently using other medications for alcohol dependence
  • People with known allergies to CBD (Cannabidiol) or related compounds
  • Those with serious mental health conditions that are not well-controlled
  • People with a history of seizures or epilepsy
  • Individuals participating in other clinical trials
  • Those unable to provide informed consent
  • People with severe heart conditions
  • Individuals with unstable medical conditions that require frequent medication changes
  • Those who cannot commit to regular follow-up visits
  • People who have used any illegal substances in the past 30 days
  • Individuals with a history of severe adverse reactions to similar treatments
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Investigated drugs

Cannabidiol (CBD) Cannabidiol is a natural compound found in cannabis plants. Unlike THC (another cannabis compound), CBD does not cause a "high" feeling. In this trial, it is being studied as a potential treatment for people who want to stop drinking alcohol. CBD may help reduce alcohol cravings and support patients in maintaining abstinence from alcohol. This medication is being tested to see if it can help people who are dependent on alcohol and are seeking treatment to quit drinking.

What is already known about the treatment

Cannabidiol (CBD) - A naturally occurring compound derived from the cannabis plant that is administered orally in the form of oil, capsules, or tablets for the treatment of various conditions, including alcohol dependence. This non-psychoactive substance works by interacting with the body's endocannabinoid system, particularly affecting neurotransmitter systems involved in addiction and reward pathways in the brain. Currently undergoing Phase II clinical trials to evaluate its effectiveness in reducing alcohol consumption and improving biochemical markers in patients with alcohol dependence, CBD belongs to the class of cannabinoids and has shown promising potential in addiction medicine without causing the intoxicating effects associated with THC.

Investigated diseases

Alcohol Dependence - A chronic medical condition characterized by an inability to control or stop drinking alcohol despite negative consequences. The condition involves both physical and psychological dependence, where the body adapts to regular alcohol consumption and requires increasing amounts to achieve the desired effect. People with alcohol dependence often experience strong urges to drink and may continue drinking even when it causes problems in their lives. The condition typically develops gradually over time, with changes occurring in brain chemistry that affect judgment, behavior, and emotional regulation. When alcohol use is reduced or stopped, withdrawal symptoms may occur, indicating physical dependence.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504439-42-01Protocol codePLACONCANALDEEstimated enrolment118 patientsSponsorHospital Universitario 12 De Octubre

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).