Study of cannabidiol for treating alcohol dependence in adults seeking abstinence

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What is this study about?

The study focuses on people with alcohol dependence, a condition where a person cannot stop drinking despite harmful effects. The treatment being tested is cannabidiol, a compound derived from the cannabis plant that does not cause a high. Participants will receive either the cannabidiol oral solution or a placebo, which looks the same but contains no active drug.

The purpose of the study is to determine whether cannabidiol can help individuals with alcohol dependence reduce drinking and achieve abstinence. Participants will take the study medication by mouth each day for several weeks and will attend regular visits where they will answer questions about their drinking using a method called the Timeline Follow-back (a calendar‑based interview that asks people to recall how much they drank each day) and will have a blood test called Carbohydrate Deficient Transferrin (a marker that rises when a person drinks heavily).

The study will also look at how the medication affects the body’s endocannabinoid system (the natural system that interacts with cannabis‑like substances) and will monitor any side effects to assess safety. Throughout the trial, participants will have periodic medical check‑ups and questionnaires to track psychological symptoms related to drinking.

1 enrollment and consent

after joining the study, you sign an informed consent form that explains the purpose and procedures.

screening tests are performed to confirm eligibility for the trial.

2 baseline assessments

a detailed interview records your recent alcohol use using the timeline follow-back questionnaire.

a blood sample is taken to measure carbohydrate deficient transferrin, a marker of alcohol consumption.

3 randomization

you are randomly assigned to receive either cannabidiol or a matching placebo without knowing which one you receive.

4 start of medication

if assigned to the active group, you take an oral solution of cannabidiol at a dose of 600 mg each day.

if assigned to the placebo group, you take a matching oral solution that does not contain active medication.

the medication is taken for the entire treatment phase as defined by the study protocol.

5 regular follow‑up visits

you attend scheduled visits, usually every week or month, where study staff check your health, record any side effects, and ask about alcohol use.

additional blood samples may be collected to repeat the carbohydrate deficient transferrin test.

6 end of treatment assessment

at the final visit, the same questionnaires and blood tests performed at baseline are repeated.

the data are used to compare changes in alcohol consumption and laboratory markers.

7 study completion

after the last assessment, the trial ends for you and you receive information about standard care options.

your individual results are not shared with you, but the overall study findings will be reported.

Who Can Join the Study?

Be between 18 and 65 years old.
Have a diagnosis of moderate or severe alcohol use disorder (AUD) as defined by the DSM‑5 (the handbook doctors use to classify mental health conditions).
Be able to give voluntary informed consent (agree to join after understanding what the study involves).
Have had at least 8 heavy drinking days in the 30 days before screening – a heavy drinking day means 4 or more drinks for a woman or 5 or more drinks for a man.
If you are of childbearing potential (you could become pregnant or cause a pregnancy), you must agree to use an approved form of contraception (birth control) from the time of screening until the study ends.
Be able to provide at least two locators (contact persons who can help researchers reach you if needed).
Express a desire to cut down or stop drinking alcohol.

Who Cannot Join the Study?

Having an active alcohol withdrawal that scores higher than 7 on a standard withdrawal rating scale (CIWA‑Ar), which means the withdrawal symptoms are fairly severe.
Being pregnant or currently breastfeeding.
Taking certain medicines that could interfere with the study, such as marijuana (cannabinoids), other addiction treatments, or many drugs that affect liver enzymes (these are chemicals the liver uses to process medicines).
Having an allergy to any ingredient in the study medication.
Receiving any medical treatment for alcohol use disorder other than support groups like AA (Alcoholics Anonymous) or similar 12‑step programs.
Having stayed in a psychiatric hospital in the past year, except for a short stay for alcohol detox or a long emergency department visit.
Testing positive on a urine drug screen for marijuana (THC), cocaine, or opioids at the screening visit.
Having medical problems that make participation unsafe, such as severe alcohol withdrawal that needs hospital care or significantly poor liver function.
Having a diagnosed mental health condition such as schizophrenia, schizoaffective disorder, or bipolar disorder.
Being judged by the study doctor to be at high risk for serious emotional or behavioral problems, such as a serious personality disorder, antisocial behavior, major current stress, or lacking supportive relationships.
Having current, significant suicidal thoughts or actions, any suicide attempt in the past year, a history of serious suicide attempts that required hospital care, or serious homicidal thoughts.
Having a history of a severe head injury with loss of consciousness lasting more than 24 hours.
Having a current mild marijuana use disorder or a moderate to severe disorder for any other drug (except alcohol or nicotine).
Showing important abnormalities in lab tests, such as very poor liver function, serious problems with blood counts, or major metabolic issues.
Having ongoing legal problems that are likely to lead to imprisonment within the next 12 weeks.

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	04.05.2026

Trial locations

Cannabidiol is a natural substance derived from the cannabis plant. In this study it is being given as an oral solution to people who are dependent on alcohol. Researchers want to see if taking cannabidiol can help participants drink less and improve a blood test (called Carbohydrate Deficient Transferrin) that reflects alcohol use. By comparing the results of those who receive cannabidiol with those who receive a placebo, the trial aims to find out whether cannabidiol can support people who are trying to stop drinking.

Alcohol dependence – Alcohol dependence is a condition where a person feels a strong need to drink alcohol regularly. Over time, they may find it hard to control how much they drink and may need larger amounts to feel the same effect. The body becomes accustomed to alcohol, and stopping can cause discomfort such as cravings or mild withdrawal symptoms. Drinking may take up more of a person’s time and affect daily activities. As the condition continues, the person may prioritize drinking over other responsibilities and relationships. The pattern often becomes more stable and difficult to change without help.

Trial ID:

2023-504439-42-03

Protocol code:

PLACONCANALDE

Trial Phase:

Therapeutic exploratory (Phase II)

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