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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Psykiatrisk Center Kobenhavn	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Dry Extract From Psilocybe Cubensis (15-25:1), Extraction Solvent: Methanol

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.

Investigated diseases:

Alcohol use disorder

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 ID:

2024-517497-17-01

Protocol code:

PSILO4ALCO

NCT ID:

NCT05416229

Trial Phase:

Human Pharmacology (Phase I) – Other

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