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Study on Psilocybin for Patients with Alcohol Use Disorder and Depression Symptoms

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of psilocybin in individuals with alcohol use disorder who also experience symptoms of depression. The study aims to explore the feasibility of using psilocybin, a chemical substance, as a treatment option. Participants will receive either a standard dose of psilocybin or a very low dose, which serves as a control, in the form of capsules taken orally.

The purpose of the study is to assess how practical it is to conduct this type of research. Participants will be involved in two sessions where they will take psilocybin. The study will monitor various aspects, such as the number of participants who complete both sessions, changes in drinking habits, and any shifts in depression symptoms. The study will also collect information on participants' experiences and any changes in their quality of life related to alcohol use.

Throughout the study, participants will be asked to complete questionnaires and provide blood samples to help researchers understand the effects of psilocybin on the body and mind. The study will also look at brain activity and other biological markers to gain a deeper understanding of how psilocybin might help with alcohol use disorder and depression. The trial is expected to continue until early 2026, with recruitment starting in 2024.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of severe alcohol use disorder and a Beck Depression Inventory score of 14 or higher.

    The assessment will also ensure that the last drink was consumed between 60 and 14 days before this visit and that there was at least one heavy drinking day during the last drinking period.

  2. Step 2

    Consent and insurance verification

    You will be required to provide informed and signed consent to participate in the study.

    Verification of health insurance coverage or beneficiary status will be conducted.

  3. Step 3

    Psilocybin administration session 1

    The first session involves the administration of psilocybin in capsule form for oral use. The dosage and specific details will be provided during the session.

    Monitoring will occur during the session to observe any effects and ensure safety.

  4. Step 4

    Integration session 1

    The day after the first psilocybin administration, an integration session will take place. This session is designed to help process the experience.

    Qualitative analysis of the session will be conducted to gather insights.

  5. Step 5

    Psilocybin administration session 2

    A second psilocybin administration session will be conducted, similar to the first session.

    Monitoring will again be in place to ensure safety and observe effects.

  6. Step 6

    Integration session 2

    Following the second psilocybin session, another integration session will occur to help process the experience.

    Further qualitative analysis will be conducted.

  7. Step 7

    Follow-up assessments

    Follow-up assessments will be conducted at various intervals, including weeks 3, 6, and 12, to evaluate changes in alcohol use, depression, and other psychological factors.

    These assessments will include questionnaires and possibly blood sampling for further analysis.

  8. Step 8

    Completion of study

    Upon completion of all sessions and assessments, the study will conclude.

    Data collected will be used to evaluate the feasibility and effects of psilocybin in treating alcohol use disorder with depressive symptoms.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of severe alcohol use disorder according to the DSM-5. (DSM-5 is a manual used by healthcare professionals to diagnose mental disorders.)
  • The patient must have a BDI II score of 14 or higher. (BDI II stands for Beck Depression Inventory, which is a questionnaire used to measure the severity of depression.)
  • The patient's last drink must have been consumed between 60 and 14 days before the inclusion visit.
  • The patient must have had at least one HDD during the last drinking period. (HDD stands for Heavy Drinking Day, which means a day when a large amount of alcohol was consumed.)
  • The patient must have given their informed and signed consent to participate in the study.
  • The patient must be insured or be a beneficiary of a health insurance plan.
  • The patient must be at least 18 years old.

Who cannot join the trial?

2 criteria

  • Patients with a history of **alcohol use disorder** cannot participate. This means if you have had problems with alcohol in the past, you may not be eligible.
  • Patients with **depressive symptoms** related to alcohol use disorder are excluded. This refers to feelings of sadness or depression that are linked to alcohol use.
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Investigated drugs

Psilocybin is a substance that is being studied for its potential effects on mental health conditions. In this trial, it is being used to see if it can help people who have problems with alcohol use and also experience symptoms of depression. Psilocybin is known for its ability to cause changes in perception, mood, and thought, which is why researchers are interested in its possible benefits for mental health. The goal is to understand if psilocybin can help improve the symptoms of depression and reduce alcohol use in people who are struggling with both issues.

What is already known about the treatment

Psilocybin – Psilocybin is administered orally, typically in the form of capsules or tablets. It is currently being studied in clinical trials for its potential use in treating alcohol use disorder, especially in individuals who also experience depressive symptoms. The main therapeutic indication for psilocybin in this context is to help reduce alcohol consumption and improve mood. At the molecular level, psilocybin works by affecting serotonin receptors in the brain, which can alter mood and perception. It is classified as a psychedelic compound, which means it can cause changes in perception, mood, and cognitive processes.

Investigated diseases

Alcohol Use Disorder – Alcohol use disorder is a medical condition characterized by an impaired ability to stop or control alcohol consumption despite adverse social, occupational, or health consequences. It often begins with occasional drinking that gradually increases in frequency and quantity. Over time, individuals may develop a tolerance, requiring more alcohol to achieve the same effects. As the disorder progresses, individuals may experience withdrawal symptoms when not drinking, such as anxiety, tremors, or nausea. The condition can lead to significant disruptions in daily life, affecting relationships, work, and overall well-being. It is a chronic condition that can vary in severity, from mild to severe, depending on the number of symptoms present.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506647-42-00Protocol codeIRESP/2022/AL-01Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Nimes

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