Study on Psilocybin-Assisted Therapy for Patients with Severe Alcohol Use Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with Severe Alcohol Use Disorder. The treatment involves the use of PEX010 Psilocybin Capsules, which contain a substance called psilocybin. Psilocybin is derived from a type of mushroom known as Psilocybe cubensis. The study will compare the effects of a high dose of psilocybin (30 mg) with a lower dose (5 mg) that acts as an active placebo. Both doses will be given alongside supportive therapy during a 28-day inpatient alcohol rehabilitation program.

The purpose of the study is to see how effective and safe psilocybin-assisted therapy is in helping people reduce their alcohol consumption. Participants will be monitored for changes in their drinking habits from before they start the program until four weeks after they leave the hospital. The study will also look at how easy it is to recruit and keep participants in the program, as well as any safety concerns that may arise.

Throughout the study, participants will receive therapy sessions to help them prepare for and integrate the experience of taking psilocybin. The study will also explore various psychological and cognitive aspects, such as changes in mood, anxiety, and the ability to cope with cravings. The goal is to better understand how psilocybin, combined with therapy, can support recovery from alcohol use disorder.

1 joining the study

Upon joining the study, participants must meet specific criteria, including being between 21 and 70 years old, having a diagnosis of severe alcohol use disorder, and being in good physical health.

Participants must agree to abstain from alcohol and other psychoactive substances during the study and follow-up period.

2 detoxification program

Participants undergo a 4-week alcohol detoxification program at a designated hospital.

Abstinence from alcohol is monitored using a breathalyzer during unannounced checks.

3 preparation sessions

Participants attend preparation sessions to understand the study protocol and the psilocybin-assisted therapy process.

These sessions include discussions about expectations and the therapy’s potential effects.

4 psilocybin administration

Participants receive psilocybin capsules orally. The dosage is either 25 mg or 5 mg, depending on the study group.

The administration occurs during the inpatient rehabilitation program, with supportive psychotherapy provided.

5 integration sessions

Following psilocybin administration, participants engage in integration sessions to process their experiences.

These sessions help participants understand and incorporate their experiences into their recovery journey.

6 follow-up period

Participants are monitored for changes in alcohol consumption from pre-hospitalization to four weeks post-hospital discharge.

Self-reported alcohol consumption is corroborated with blood tests to ensure accuracy.

7 additional assessments

Participants undergo various assessments, including psychological and neurocognitive evaluations, to measure the therapy’s impact.

These assessments include questionnaires and interviews to explore changes in attitudes and behaviors related to alcohol use.

Who Can Join the Study?

Must be a male or female between 21 and 70 years old with a minimum Body Mass Index (BMI) of 17.5 kg/m², wanting to stop or reduce drinking.
Must be able to provide voluntary written consent after understanding the study details.
Must be participating in a 4-week alcohol detoxification program at Brugmann University Hospital.
Must stay away from alcohol during the detoxification program, which will be checked with a breathalyzer.
Must have a normal understanding of the French language.
Must be part of the Belgian social security system.
Must agree to have all therapy sessions and interviews recorded.
Must have a diagnosis of Severe Alcohol Use Disorder (sAUD), confirmed by a specific interview called the Mini International Neuropsychiatric Interview.
Must not be receiving any medication for sAUD and must be willing to participate in all study activities, including attending sessions and completing evaluations.
Female participants who can have children must have a negative pregnancy test at the start and before taking psilocybin.
Women who can have children must use a reliable method of birth control during the study and for four weeks after leaving the hospital.
Men with partners who can have children should use a condom during the study and for four weeks after leaving the hospital.
Must be in good physical health without any unstable medical conditions, as determined by medical tests and examinations.
Must be willing to avoid using any mind-altering substances during the study and follow-up period.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Severe Alcohol Use Disorder cannot participate. This means the study is only for those who have a serious problem with alcohol.
Participants must be within a certain age range, typically adults, but the exact ages are not specified here.
Both men and women are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population may be excluded. This term refers to groups who might need special protection, like those with certain health conditions or social situations.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
University Childrens Hospital Queen Fabiola	Brussels	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.09.2023

Trial locations

Investigated drugs:

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

Psilocybin: This is a substance that is being studied for its potential to help people with severe alcohol use disorder. In this trial, it is used in combination with supportive psychotherapy. The goal is to see if it can reduce the number of days patients engage in heavy drinking. The study compares a high dose of psilocybin to a lower dose to understand its effects better.

Supportive Psychotherapy: This is a type of therapy provided to patients during their stay in an alcohol rehabilitation program. It involves talking with a therapist to support the patient’s mental health and help them cope with their alcohol use disorder. The therapy is used alongside psilocybin to see if it enhances the treatment’s effectiveness.

Investigated diseases:

Alcohol abuse

Severe Alcohol Use Disorder – This condition is characterized by an inability to control or reduce alcohol consumption despite negative consequences. Individuals with this disorder often experience a strong craving for alcohol and may spend a significant amount of time drinking or recovering from its effects. Over time, they may develop a tolerance, requiring more alcohol to achieve the same effects, and may experience withdrawal symptoms when not drinking. The disorder can lead to significant impairments in daily functioning, affecting personal relationships, work, and health. It often involves a cycle of excessive drinking, attempts to cut down, and relapse. The progression of the disorder can vary, with some individuals experiencing periods of remission and others facing chronic issues.

Trial ID:

2024-518061-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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