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Study of Single Dose Psilocybin Treatment for Adults with Alcohol Use Disorder

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 research study focuses on patients with Alcohol Use Disorder, a condition where a person has difficulty controlling their alcohol consumption. The study will test whether a single dose of PEX010 Psilocybin Capsules, a substance derived from mushrooms, can help reduce alcohol consumption in people with this disorder.

The study will compare the effects of psilocybin capsules to a placebo to determine if the treatment can decrease the number of days when participants consume large amounts of alcohol. The medication being tested contains dry extract from Psilocybe cubensis, which is taken as an oral capsule.

The research will last 12 weeks after the single dose administration. During this time, researchers will monitor changes in participants' drinking patterns and overall well-being. The study is designed so that neither the participants nor the researchers know who receives the actual medication or the placebo until the study is complete, which helps ensure accurate results.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo evaluation to confirm your diagnosis of Alcohol Use Disorder

    Your alcohol consumption patterns will be assessed using standardized questionnaires

    Basic health measurements including body weight will be recorded

  2. Step 2

    Treatment administration

    You will receive a single dose of either PEX010 Psilocybin Capsules (25mg) or a placebo

    The capsule will be taken by mouth

    During the session, your experiences will be documented through questionnaires and video/audio recordings

  3. Step 3

    Immediate follow-up

    Your emotional responses and experiences will be assessed using specific questionnaires

    Blood samples will be collected to measure medication levels in your system

    Brain activity will be monitored through fMRI (brain scanning)

  4. Step 4

    12-week monitoring period

    Your alcohol consumption will be tracked for 12 weeks

    Regular assessments will include:

    Recording of drinking patterns and alcohol-free days

    Completion of questionnaires about alcohol cravings and quality of life

    Blood tests to check liver function and other health markers

  5. Step 5

    Final evaluation

    Assessment of changes in alcohol consumption patterns

    Final completion of all questionnaires

    Final blood tests and health measurements

    Brain scanning to assess changes in brain activity

Who can join the trial?

5 criteria

  • Must be between 20 and 70 years old
  • Body weight must be between 60 and 95 kilograms
  • Must be diagnosed with Alcohol Use Disorder (AUD) according to two medical classification systems: - DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) - ICD-10 (International Classification of Diseases)
  • Must score 15 or higher on the Alcohol Use Disorder Identification Test (AUDIT), which is a screening tool that assesses drinking behaviors
  • Must have had at least 5 heavy drinking days in the past 28 days before joining the study, where heavy drinking is defined as: - For men: more than 60 grams of alcohol per day - For women: more than 48 grams of alcohol per day (This is measured using a Timeline Followback method, which tracks daily drinking)

Who cannot join the trial?

14 criteria

  • Current diagnosis of severe psychiatric disorders (such as schizophrenia, bipolar disorder, or severe depression)
  • History of suicide attempts or current suicidal thoughts
  • Presence of any serious medical conditions that could affect safety during the trial
  • Current use of medications that could interact with psilocybin
  • Pregnancy or breastfeeding
  • History of severe adverse reactions to psychedelic substances
  • Unable to commit to the full 12-week study period
  • Current participation in another clinical trial
  • Liver or kidney disease that could affect drug metabolism
  • History of seizures or other neurological disorders
  • Inability to provide informed consent
  • Substance use disorder involving drugs other than alcohol
  • History of severe withdrawal symptoms from alcohol
  • Unwillingness to follow safety guidelines during the trial
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Investigated drugs

Psilocybin is a naturally occurring psychedelic compound that works by activating specific receptors in the brain (5-HT2A receptors). In this trial, it is being studied as a potential treatment for alcohol use disorder. When administered in a controlled medical setting, psilocybin may help reduce alcohol consumption patterns. The medication is given as a single dose under careful medical supervision.

What is already known about the treatment

Psilocybin - A naturally occurring psychedelic compound administered orally that acts primarily as a serotonin receptor (5-HT2A) agonist in the brain. Currently being investigated in clinical trials for treating Alcohol Use Disorder, this substance belongs to the class of classical psychedelics and has shown promising potential in addiction treatment. The compound works by temporarily altering neural connectivity patterns and promoting neuroplasticity, which may help break established patterns of addictive behavior and create new perspectives on alcohol consumption. This medication is typically administered in a single controlled dose under careful medical supervision in a supportive clinical setting, with effects lasting several hours.

Investigated diseases

Alcohol Use Disorder - A chronic brain condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. The disorder develops when regular alcohol consumption becomes compulsive and causes changes in the brain's reward and stress circuits. People with this condition may drink larger amounts of alcohol over time and experience withdrawal symptoms when rapidly decreasing or stopping alcohol use. The disorder often leads to building tolerance, requiring more alcohol to achieve the same effects. Individuals may spend a great deal of time obtaining, using, or recovering from alcohol use and may continue drinking even when it causes problems with daily life activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517497-17-01Protocol codePSILO4ALCOEstimated enrolment100 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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