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Study on Cannabidiol for Treating Alcohol Dependence in Patients Seeking 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 is focused on studying alcohol dependence, a condition where individuals have a strong craving for alcohol and find it difficult to control their drinking. The trial will test the effects of a treatment using cannabidiol, which is a chemical compound found in cannabis plants, known for its potential therapeutic benefits. Participants in the study will receive either cannabidiol in the form of an oral solution or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate the potential of cannabidiol in helping individuals with alcohol dependence reduce their alcohol consumption and achieve abstinence. The study will monitor changes in alcohol consumption and certain markers in the blood that indicate alcohol use. Participants will be involved in the study for a period of up to eight weeks, during which they will take the oral solution and attend regular check-ups to assess their progress and any effects of the treatment.

Throughout the study, researchers will also assess the safety and tolerability of cannabidiol in individuals with alcohol dependence. This will help determine if cannabidiol can be a safe and effective option for managing alcohol dependence and reducing the psychological symptoms associated with alcohol use. The study aims to provide valuable insights into the role of the endocannabinoid system, which is involved in regulating various bodily functions, in alcohol dependence.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of alcohol dependence, and the ability to provide informed consent.

    Participants must have experienced at least 8 heavy drinking days in the 30 days prior to the assessment.

  2. Step 2

    Consent and baseline evaluation

    Participants provide voluntary informed consent to participate in the trial.

    A baseline evaluation is conducted, which includes assessments of alcohol consumption and psychological symptoms.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either cannabidiol or a placebo.

    The medication is administered as an oral solution.

    The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.

  4. Step 4

    Ongoing assessments

    Regular assessments are conducted to monitor alcohol consumption using the Timeline Follow-back (TLFB) method.

    Blood tests are performed to measure the percent of Carbohydrate Deficient Transferrin (CDT) in serum.

  5. Step 5

    Safety and tolerability monitoring

    Participants are monitored for any side effects or adverse reactions to the medication.

    The safety and tolerability of cannabidiol are evaluated throughout the trial.

  6. Step 6

    Completion and final evaluation

    Upon completion of the trial, a final evaluation is conducted to assess the overall efficacy of cannabidiol in managing alcohol dependence.

    Participants' psychological symptoms and the endocannabinoid system are also evaluated.

Who can join the trial?

7 criteria

  • Participants must be males or females aged between 18 and 65 years old.
  • Participants must have a DSM-5 diagnosis of moderate or severe AUD (Alcohol Use Disorder). The DSM-5 is a manual used by healthcare professionals to diagnose mental disorders.
  • Participants must be able to provide voluntary informed consent, meaning they understand the study and agree to participate.
  • Participants must have had at least 8 heavy drinking days in the 30 days before the screening. A heavy drinking day is when a woman has 4 or more drinks, or a man has 5 or more drinks.
  • If participants are of childbearing potential (able to have children), they must be willing to use an approved form of contraception from the screening and throughout the trial.
  • Participants must be able to provide at least two locators, which means contact information for people who can help reach them if needed.
  • Participants must express a desire to cut down or stop drinking.

Who cannot join the trial?

8 criteria

  • Individuals who are not seeking treatment to stop drinking alcohol cannot participate.
  • People who are not willing to stop drinking alcohol are excluded.
  • Participants must not have any other serious health conditions that could interfere with the study.
  • Individuals who are pregnant or breastfeeding cannot take part in the study.
  • People who are currently using illegal drugs are not eligible.
  • Participants must not have a history of severe mental health disorders that are not well controlled.
  • Individuals who are unable to provide informed consent, which means they cannot understand and agree to the study, are excluded.
  • People who are participating in another clinical trial at the same time are not allowed to join.
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Investigated drugs

Cannabidiol (CBD) is being studied for its potential to help people with alcohol dependence. The trial aims to see if CBD can reduce alcohol consumption and improve certain blood markers related to alcohol use. CBD is a compound found in cannabis plants, but it does not cause a "high" like some other components of cannabis. Researchers are exploring whether CBD can support individuals in their efforts to stop drinking alcohol.

What is already known about the treatment

Cannabidiol (CBD) – Cannabidiol is administered orally, typically in the form of oil or capsules. It is currently being studied in clinical trials for its potential use in treating alcohol dependence. The main therapeutic indication for CBD in this context is to help manage alcohol dependence and support individuals seeking to achieve abstinence. At the molecular level, CBD interacts with the endocannabinoid system, which may influence neurotransmitter release and reduce cravings or withdrawal symptoms. It is classified as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Alcohol Dependence – A chronic condition characterized by an inability to control or reduce alcohol consumption despite negative consequences. Individuals with alcohol dependence often experience a strong craving for alcohol and may develop a tolerance, requiring more alcohol to achieve the same effects. Over time, they may experience withdrawal symptoms when not drinking, which can include anxiety, tremors, and nausea. The condition can lead to significant social, occupational, and health problems. It often involves a cycle of drinking, withdrawal, and relapse. The progression of alcohol dependence can vary, with some individuals experiencing periods of heavy drinking followed by attempts to quit or reduce intake.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504439-42-00Protocol 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).