Study on Cannabidiol for Treating Alcohol Dependence in Patients Seeking Abstinence

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Universitario 12 De Octubre	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.01.2025

Trial locations

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.

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 ID:

2023-504439-42-00

Protocol code:

PLACONCANALDE

Trial Phase:

Therapeutic exploratory (Phase II)

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