Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver: a phase 2 clinical trial.- The CARAMEL Study

The CARAMEL study is testing a promising new approach to help people with alcohol use disorder. Researchers want to see if Cannabidiol (CBD), a component found in cannabis, can help reduce how much alcohol people drink. They are also looking at how this medicine might protect the brain and liver from the effects of alcohol. This study is an important step called 'Phase 2', which means they're exploring if the treatment is safe and effective in a larger group of people. Participants will be taking either CBD or a dummy pill, and their alcohol consumption will be carefully monitored over several weeks. It's hoped that this research could lead to new treatments for this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Le Vinatier

Enrolment target

Start

26 Nov 2024

Psychiatric disorders

What is this study about?

The CARAMEL study is a research project looking into whether a substance called Cannabidiol, often known as CBD, can help people who are struggling with alcohol use disorder. Alcohol use disorder is a condition where a person has trouble controlling their drinking, often leading to problems with their health, work, or relationships.

Researchers want to see if taking CBD could help people drink less alcohol. They are also investigating whether CBD can have a positive effect on the brain and liver, which can both be damaged by long-term heavy drinking. This is a "Phase 2" study, which means it's an important step where scientists are looking more closely at how well the treatment works and if it's safe for people.

Participants in the study will be split into two groups. One group will receive CBD, and the other will receive a dummy pill that looks just like the CBD but contains no active medicine (this is called a placebo). This comparison helps the researchers know for sure if any changes are due to the CBD itself and not just other factors. They will carefully track how much alcohol people drink and also check for changes in physical and mental health, including liver health and brain function.

Key takeaways

The CARAMEL study is testing CBD for alcohol use disorder.
It aims to see if CBD helps reduce drinking and affects the brain and liver.
Participants will receive either CBD or a placebo (dummy pill).
The study involves keeping a diary of drinking and regular health checks including blood tests.
This is a Phase 2 study, looking for safety and effectiveness in a larger group.
It could lead to new treatment options for alcohol use disorder.

Who may be eligible?

To be able to take part in this study, participants need to be adults, meaning they must be 18 years old or older. There is no upper age limit, so people of any adult age can potentially join.

Both men and women are welcome to participate in this research. The study aims to include a diverse group of people to make sure the results are as widely applicable as possible.

Crucially, participants must have a diagnosis of alcohol use disorder. Other specific health conditions or medications might also affect whether someone can join, but those details would be discussed with the study team.

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?
Do you have a diagnosis of alcohol use disorder?
Are you able to attend regular appointments for 12 weeks?
Are you willing to keep a daily record of your alcohol intake?
Are you comfortable with blood tests and questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CARAMEL study, you would first go through a screening process to make sure it's suitable for you. Once enrolled, you would receive either the active CBD medicine or a dummy pill (placebo) to take regularly, as instructed by the study team.

Throughout the study, which lasts for 12 weeks, you would be asked to keep a daily record of your alcohol consumption. You would also have regular appointments at the study clinic. During these visits, the research team would carry out various assessments. These include blood tests to check your liver and other health markers, and questionnaires to understand your drinking habits, mood, anxiety levels, and overall quality of life. Some visits might also involve brain scans (MRI) or ultrasound exams to look at your liver. There will also be tests to check your thinking, memory, and attention.

After initially taking measurements at the start, the study will focus on your alcohol consumption in the last 28 days (weeks 8 to 12) of the study period. The total duration of active participation, including follow-up, would be around 12 weeks.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a potential new treatment for alcohol use disorder under close medical supervision, and contributing to important scientific knowledge that could help others. However, there's no guarantee that you will receive the active medicine or that it will work for you. As with any medicine, there could be potential side effects from CBD, which would be explained in detail by the study team. You always 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
France

Common questions

What is Cannabidiol (CBD)?

CBD is a natural substance found in the cannabis plant. Unlike THC, another well-known substance from cannabis, CBD does not make you feel 'high'.

What is 'alcohol use disorder'?

Alcohol use disorder is a medical condition where someone has problems controlling their drinking, often spending a lot of time drinking or recovering from drinking, and it affects their life negatively.

Will I know if I'm getting CBD or a dummy pill?

No, during the study, neither you nor the study doctors will know whether you are receiving the CBD or the dummy pill. This is called 'blinding' and helps ensure the study results are fair and accurate.

What kind of tests will I have?

You might have blood tests, questionnaires about your health and drinking, and possibly special scans of your brain or liver. These tests help the researchers understand how the medicine is working.

How long does the study last?

The main part of the study where you take the medication and have assessments will last for 12 weeks.