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CompletedNot applicable

Psilocybin in Alcohol Use Disorder With Comorbid Depression

NCT06235411 · PAD · Centre Hospitalier Universitaire de Nīmes

Closed to entry
Status
Not accepting participants
Not applicable
Phase
30
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approximately 6 hours, psilocybin action appears to be beneficial for preventing alcohol relapse in recently weaned people suffering from comorbid depression. Whilst the public perception of psilocybin therapy is poorly documented in France, the rapid changes in the legal status of psilocybin elsewhere, the positive media coverage of recent trials in depression, and the recent designation as an "innovative therapy" by the FDA could lead to the refusal of randomization of eligible participants. It is therefore essential to evaluate the feasibility and acceptability of psilocybin treatment and blinded randomized design in our clinical population of hospitalized patients with AUD and depressive symptoms. Recent data suggest that the effect size of psilocybin is much higher than other currently available treatments. However, this paradigm shift must be confirmed in our cohort of people with AUD and depressive symptoms, and in the context of treatment in addition to usual care, by an estimation of the expected effect size based on real data. This will allow the sample size to be accurately calculated for a large-scale randomized clinical trial. Finally, the potential mechanisms of action of psilocybin to prevent relapse in AUD with comorbid depression after withdrawal need to be documented. The objective of this pilot study is to evaluate the feasibility, acceptability, neural mechanisms and preliminary results of the effectiveness of psilocybin in the treatment of AUD and depressive symptoms after withdrawal, in addition to usual treatment. The study authors hypothesize that two oral administrations of 25 mg psilocybin at three-week intervals versus a control condition (1 mg psilocybin), in addition to the usual treatment, will be acceptable and feasible in recently withdrawn individuals suffering from AUD and depressive symptoms, between 14 and 60 days after their last alcohol consumption

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility of the intervention between groups

    Measured over After 2nd experimental session (Week 4)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder. * BDI II (Beck Depression Inventory) score ≥ 14. * Last alcohol consumption must have occurred between 60 and 14 days prior to study inclusion. The patient must have had at least one heavy drinking day during the last period of alcohol consumption. NB: The last period of alcohol consumption prior to inclusion is defined as the last 4 weeks counted from the last drink. * Patient with free and informed consent. * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is participating in an interventional study involving a drug or in a clinical trial according to the REC. * The subject is in a period of exclusion determined by a previous study * The subject unable to express consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Schizophrenic disorder, or any history of psychotic disorder according to the clinician's judgment. * Past or current manic or hypomanic episode. * Need for antipsychotic treatment that may interfere with psilocybin. * Need for treatment with monoamine oxidase inhibitors (MAOIs) which may interfere with psilocybin. * Current scripted suicidal ideation (according to clinician judgment) corresponding to a "high risk" score on the Columbia-Suicide Severity Rating Scale (C-SSRS). * First-degree family member diagnosed with psychotic disorder or bipolar disorder type 1. * High risk of negative emotional or behavioral response based on the investigator's clinical judgment (e.g., signs of serious personality disorders, antisocial behavior, severe current stressors, lack of meaningful social support) * Patient with dementia or severe cognitive impairment (as judged by the clinician). * CIWA-R score ≥ 8. * Medical conditions that would prevent safe participation in the trial; for example: seizure disorders, significant impairment of liver function, coronary heart disease, history of arrhythmia, heart failure, uncontrolled hypertension (greater than 165/95 mmHg at screening), history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, stenotic peptic ulcer, pyloroduodenal obstruction, symptomatic enlarged prostate or bladder neck obstruction), Uncontrolled type I or type II diabetes or history of ketoacidosis, hyperglycemic coma or severe hypoglycemia with loss of conscience * History of hallucinogen use disorder, 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). * Serious ECG abnormalities (e.g., signs of ischemia, myocardial infarction, QTc prolongation (QTc \> 0.45 seconds for men, QTc \> 0.47 seconds for women). * Hypersensitivity to the active ingredient or excipients * No access to email. * Insufficient understanding of French to complete the questionnaires. * Patient for whom it is impossible to provide informed information. * Pregnant or breastfeeding patient. * Patient planning a pregnancy

Where

1 study site

FacilityCityRegionCountry
CHUNîmesNîmesFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06235411 on ClinicalTrials.gov →

Last updated in the registry 2025-03-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits