Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Psilocybin in alcohol use disorder with comorbid depression - Randomized double-blind controlled pilot study.

This research is an early-stage (Phase II) study investigating psilocybin, a substance found in some mushrooms, as a potential treatment for people with both alcohol use disorder and depression. The main goal is to see how practical it is for patients to complete the two planned psilocybin treatment sessions. Researchers will also look at how many people sign up and stay in the study, and how much they drink. They will monitor changes in mood, anxiety, and overall quality of life. This helps them understand if psilocybin could be a promising future treatment for these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nimes

Enrolment target

Start

20 Dec 2023

alcohol use disorder

What is this study about?

This research study is looking at a new way to help people who are struggling with both alcohol use disorder (sometimes called alcoholism) and depression. It's an early-stage study, meaning it's one of the first steps to see if a treatment could work. The treatment being studied is psilocybin, which is a substance that comes from certain types of mushrooms. Scientists want to understand if psilocybin could be helpful for these conditions.

The main aim of this study is to check how practical and easy it is for people to go through the treatment. They are particularly interested in how many participants complete the two planned psilocybin sessions. This helps the researchers understand if this type of treatment is something that can be realistically offered to patients in the future. They will also keep track of how many people join the study, how regularly they attend appointments, and whether people stay in the study until the end.

Beyond simply looking at how practical the study is, the researchers will also be gathering information on how participants' drinking habits change. They will look at things like how often people have heavy drinking days and their overall alcohol consumption. They'll also check if mood, anxiety, and general well-being improve. This information will help them decide if larger studies are needed to explore psilocybin as a potential treatment for alcohol use disorder and depression.

Key takeaways

It's an early-stage study testing psilocybin for alcohol use disorder and depression.
The main goal is to see if the treatment process is practical for patients.
Researchers will also track changes in drinking, mood, and quality of life.
You need to have both alcohol use disorder and depression to be considered.
Participation involves two treatment sessions and regular check-ups over 12 weeks.

Who may be eligible?

The study is looking for adults aged 18 or older. Both men and women can take part in this research.

To be considered for this study, you would need to have both alcohol use disorder and depression. The research team will carefully check to make sure you meet all the specific requirements for the study.

There will be other detailed health requirements that determine if you can join, such as your current medications or other health conditions. These will be discussed with you by the research team to make sure the study is safe for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with alcohol use disorder?
Have you also been diagnosed with depression?
Are you willing to attend regular study appointments over several weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it would involve several visits over a period of weeks. You would have two planned sessions where you receive the study treatment, psilocybin. The researchers will be checking your health and well-being regularly throughout the study. This will include answering questionnaires about your drinking, mood, anxiety, and quality of life.

Some of these checks will happen before you start the treatment and then at different points, such as at 3, 6, and 12 weeks into the study. They might also include specific tasks to understand how you think and feel. There will be recordings of your brain activity (EEG) at certain times. The total duration of your active participation in the study is planned to be 12 weeks, though monitoring might extend slightly longer if you left the study later.

Potential risks and benefits

Potential benefits of taking part could include gaining access to an experimental treatment that might help with your alcohol use disorder and depression if other treatments haven't worked well for you. You would also be contributing valuable information that could help others in the future. Potential risks could include side effects from the psilocybin, which the research team will explain fully. As with any medical study, there's a chance the treatment may not help you, or you might experience discomfort. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain mushrooms. In this study, it's being explored as a potential treatment for alcohol use disorder and depression.

What is alcohol use disorder?

Alcohol use disorder is a medical condition where a person has trouble controlling their drinking, even when it causes problems in their life.

Is this a new treatment?

Yes, using psilocybin for these conditions is still experimental, meaning it's in the early stages of research and not yet a standard treatment.

Will I know if I'm getting psilocybin?

This is a 'double-blind' study, meaning neither you nor your study doctor will know if you are receiving psilocybin or a placebo (an inactive treatment). This helps ensure the results are fair.

How long will I be in the study?

Your active participation, including treatments and main assessments, is planned to last about 12 weeks.