AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II, Placebo-controlled trial of Cannabidiol for the treatment of alcohol dependence (PLACONCANALDE)

This study is investigating a new treatment for alcohol dependence using cannabidiol (CBD). We want to understand if CBD can reduce alcohol cravings and consumption, and improve the emotional well-being of people with alcohol dependence. The study will also carefully monitor how CBD affects the body and if it has any unwanted side effects, making sure it's safe to use. Half the people taking part will receive CBD, and the other half will receive a 'dummy' treatment called a placebo, which looks the same but contains no active medicine. This helps researchers compare the effects of CBD accurately. We're also looking at how CBD might interact with your body’s natural systems.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hospital Universitario 12 De Octubre

Enrolment target

118

Start

08 Jun 2026

alcohol dependence

What is this study about?

This study is a Phase II clinical trial, which means it's an early-stage study designed to see if a new treatment is safe and effective before more extensive trials are conducted. We're specifically focusing on cannabidiol (CBD), a compound found in the cannabis plant, to see if it can help people who are struggling with alcohol dependence. We know that alcohol dependence can seriously impact a person's life, and finding new ways to help is very important.

The main goals of this study are to find out if CBD can reduce the desire to drink alcohol and how much alcohol someone consumes. We also want to understand if CBD can help with any difficult feelings or moods that often come with trying to reduce alcohol intake. This might include feelings of anxiety or unhappiness, which can make it harder to cut down or stop drinking.

Another important part of this research is to check how CBD affects your body and if it causes any side effects. We'll be carefully monitoring your health to make sure the treatment is safe. We're also exploring how CBD might work with your body's natural systems, specifically something called the 'endocannabinoid system', which plays a part in many body functions, including mood and appetite. By understanding these aspects, we hope to learn if CBD could be a helpful new option for people needing support with alcohol dependence.

Key takeaways

This study is testing CBD for alcohol dependence.
It aims to see if CBD reduces drinking and improves mood.
Researchers will check CBD's safety and how it affects the body.
You'll either get CBD or a look-alike dummy treatment.
The study includes adults aged 18 and over who have alcohol dependence.

Who may be eligible?

To be part of this study, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can take part. Both men and women are welcome to join the study.

It's important to note that the study is specifically for individuals who have been diagnosed with alcohol dependence. This means the research is designed for people who are currently struggling with alcohol and meet certain medical criteria for dependence.

Before you can join, the study team will need to check if you meet all the necessary health requirements. This is to make sure the study is safe for you and that the results will be clear and helpful for understanding how CBD works.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been told by a doctor that you have alcohol dependence?
Are you able to attend regular clinic visits?
Are you willing to take study medication as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two groups: one receiving CBD capsules and the other receiving identical-looking dummy capsules (placebo). Neither you nor the study team will know which you are receiving until the study is over. You will need to take the study medication regularly as instructed.

Throughout the study, you will have regular visits to the clinic so the researchers can monitor your progress, how you're feeling, and if you're experiencing any side effects. These visits will likely involve questionnaires about your mood and drinking habits, and possibly some blood tests. The exact number of visits and the total duration of the study, including follow-up, will be clearly explained to you by the study team. They will make sure you understand all the assessments and what is expected of you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical monitoring and potentially from the CBD treatment itself if it proves effective for your alcohol dependence. However, there's also a chance you could receive the placebo and not experience any direct treatment effect. Potential risks could include side effects from the CBD, or from any procedures like blood tests, though these will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is CBD?

CBD stands for cannabidiol. It's a natural substance found in the cannabis plant. Unlike THC, another well-known substance from cannabis, CBD does not cause a 'high'.

What is alcohol dependence?

Alcohol dependence is a medical condition where a person has a strong craving for alcohol and feels a need to drink regularly. It can affect your health, relationships, and everyday life.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It's used so researchers can compare the real effects of the medicine against what might happen naturally or due to a person's expectations.

Will I know if I'm getting CBD or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving CBD or the placebo until the study has finished.

Is this study safe?

All clinical studies go through strict checks to ensure they are as safe as possible. Your health will be carefully monitored throughout the study, and you can withdraw at any time if you wish.