Psilocybin in alcohol use disorder with comorbid depression - Randomized double-blind controlled pilot study.

Phase 1

Recruiting

Conditions: alcohol use disorder
MedDRA version: 20.1Level: PTClassification code: 10080021Term: Alcohol use disorder Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: CTIS2023-506647-42-00

Lead Sponsor: Centre Hospitalier Universitaire De Nimes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

A patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder., BDI II score (Beck Depression Inventory) = 14., The last drink must have been consumed between 60 and 14 days before the inclusion visit., The patient must have had at least 1 HDD during the last drinking period, The patient must have given his/her informed and signed consent, The patient must be insured or beneficiary of a health insurance plan, The patient is at least 18 years old

Exclusion Criteria

Schizophrenic disorder, or any history of psychotic disorder as judged by the clinician., History of hallucinogen use disorders, any use in the past year or > 25 lifetime uses., Dependence on cocaine, psychostimulants, opioids or cannabis (last 12 months), Current non-medical use of cocaine, psychostimulants or opioids (past 30 days)., Severe ECG anomalies, No access to email., Insufficient understanding of French to complete questionnaires., past or current manic or hypomanic episode, Need for antipsychotic treatment that may interfere with psilocybin., Suicidal ideation in progress, scripted (as judged by the clinician)., First-degree relative with a diagnosis of psychotic disorder or type 1 bipolar disorder., High risk of negative emotional or behavioral response based on investigator's clinical judgment, Patients with dementia or severe cognitive impairment, Score CIWA-R = 8., Medical conditions that would prevent safe participation in the trial