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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

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

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2025

Trial locations

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.

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 ID:

2023-504439-42-01

Protocol code:

PLACONCANALDE

Trial Phase:

Therapeutic exploratory (Phase II)

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