Psilocybin in Alcohol Use Disorder With Comorbid Depression

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 5, 2024

Primary Completion Date

November 19, 2024

Study Completion Date

January 9, 2025

Conditions
Alcohol-Related DisordersDepressive DisorderAddiction
Interventions
DRUG

Psilocybin therapy

"Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.~One 25 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.~The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual)."

DRUG

Inactive Psilocybin therapy

"Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.~One 1 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.~The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual)."

OTHER

Electroencephalogram

"* Rest EEG prior to first treatment administration~* EEG during first treatment administration~* Rest EEG during integration session after second treatment administration"

OTHER

Blood samples for the analysis of immune and inflammatory profiles

Three 7ml EDTA tubes will be taken in the morning on an empty stomach at day 0 and at 3 weeks.

OTHER

stool samples

Stool sampling at day 0 and 3 weeks Analysis of intestinal microbiota is carried out on a stool sample, which is stored at -20°C for a maximum of 24 hours. The sample is then transferred cold to the CRB of the Nîmes University Hospital, where it is stored at -80°C until the microbiology laboratory can perform a group analysis.

OTHER

MRI functional and cerebral

MRI functional and cerebral at day 0 and 3 weeks

Trial Locations (1)

30029

CHU, Nîmes

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT06235411 - Psilocybin in Alcohol Use Disorder With Comorbid Depression | Biotech Hunter | Biotech Hunter