AuthorisedTherapeutic confirmatory (Phase III)Interventional

ERPPAD - Efficacy in Relapse Prevention: Psilocybin in Alcohol use disorder with Depressive symptoms

This study, called ERPPAD, is exploring if psilocybin can help people who struggle with alcohol use disorder and depression. They want to see if this medicine can stop heavy drinking from happening again. Participants will receive either psilocybin or a lower dose to see if it makes a difference. The study will carefully track how much alcohol people drink every few weeks and will also look at how their mood changes. It's in the final stages of testing, phase 3, which means researchers are trying to confirm if it works well and is safe for a larger group of people. The main goal is to find out how long it takes before someone might have a heavy drinking day. People aged 18 and over, of any gender, can take part.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Nimes

Enrolment target

172

Start

05 Jun 2026

Alcohol use disorder, depressive symptoms

What is this study about?

This study, called ERPPAD, is a really important one looking into new ways to help people who are living with two big challenges: alcohol use disorder and feelings of depression. Lots of people experience these challenges, and finding effective treatments is vital. This research is focusing on a special medicine called psilocybin.

The main idea behind the study is to see if psilocybin can help people avoid slipping back into heavy drinking. Heavy drinking is defined as having 60 grams or more of alcohol on one day – for example, about three large glasses of wine or three pints of strong lager. The researchers will be comparing different amounts of psilocybin to see if one works better than another in helping people stay sober for longer.

This study is in 'Phase 3', which means it's one of the final steps before a medicine might be considered for wider use. Researchers are working to confirm that psilocybin is both effective and safe for a larger group of people. They want to understand exactly how it might help and make sure any potential risks are carefully managed. It’s about finding out if this approach could offer real hope and support for individuals and their families.

Key takeaways

The study explores psilocybin for alcohol use disorder and depression.
It aims to see if psilocybin can help prevent heavy drinking.
Participants will receive different doses of psilocybin or a lower dose.
Heavy drinking is defined as 60g or more of alcohol in a day.
Participation involves regular clinic visits and tracking alcohol use.

Who may be eligible?

To be considered for this study, you need to be 18 years old or older. There is no upper age limit, meaning older adults are welcome to take part too. Both men and women can join the study.

The most important criteria are that you have been diagnosed with both alcohol use disorder and have symptoms of depression. These are the conditions the study is specifically designed to investigate. The research team will need to confirm these diagnoses through their assessment.

There might be other health or medication-related reasons why you wouldn't be able to join, even if you meet these main points. The study doctors will carefully check your full medical history to make sure it's safe and appropriate for you to participate.

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 diagnosed with alcohol use disorder?
Do you experience symptoms of depression?
Are you able to commit to regular study visits for up to a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for quite a long time, possibly up to a year. You'll have several visits to the study clinic, especially at the beginning and then less frequently for follow-up appointments.

The main treatments involve taking a special medicine called psilocybin, or a lower dose of it. This will be given in a controlled environment, and you'll be carefully looked after by the study team during and after you take it. There will also be talk-based support sessions. A key part of the study is tracking your alcohol consumption. This will be done every six weeks using a method called 'Timeline Follow-Back', where you'll be asked about your drinking over recent periods with the help of a calendar (either digital or paper).

You'll also be asked to fill out questionnaires about your mood, quality of life, and other feelings at various times throughout the study. These assessments help the researchers understand how the treatment might be affecting you. Some blood samples will also be taken at the start and towards the end of the study to monitor your health. The total duration of your participation will depend on the specific group you are in and how long the researchers need to follow your progress, but it could involve visits for up to 51 weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from the close medical care and support provided, and the treatment being explored could potentially help reduce your heavy drinking and improve your mood. However, psilocybin can have side effects, and some people might find the experience intense or uncomfortable. There's also no guarantee that the treatment will work for everyone, or work for you. 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
France

Common questions

What is psilocybin and what does it do?

Psilocybin is a natural substance sometimes called a 'psychedelic'. It can change how you think, feel, and see things for a time. In this study, we're exploring if it can help people change their relationship with alcohol and improve their mood.

What does 'heavy drinking' mean in this study?

For this study, heavy drinking means having 60 grams or more of pure alcohol in a single day. This is roughly equivalent to about three large glasses of wine or three pints of strong lager.

Will I know if I'm getting the real medicine or a lower dose?

No, this is a 'blinded' study, meaning neither you nor the study team will know which dose you're receiving. This helps make sure the results are fair and unbiased.

How will the study check how much alcohol I'm drinking?

Every six weeks, you'll talk with a team member about your drinking using a special calendar. This helps track your alcohol use over time.

What does 'Phase 3' mean for a clinical trial?

Phase 3 is an advanced stage of testing where researchers want to confirm that a new medicine is effective and safe in a larger group of people, before it might be considered for wider use.