Psilocybin in Alcohol Use Disorder with Depression (Relapse Prevention)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial investigates psilocybin-assisted psychotherapy as a relapse-prevention strategy for adults with severe alcohol use disorder who also have depressive symptoms. Participants receive either high-dose or low-dose psilocybin in the context of psychotherapy, following detoxification. The trial builds on prior pilot data suggesting feasibility and potential efficacy for reducing drinking days and addressing depressive symptoms. Outcomes include metrics on relapse risk and drinking behavior over a defined follow-up period. Locations include multiple French centers with centralized sponsor oversight by CHU de Nîmes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed DSM-5 diagnosis of severe AUD.
* Scale BDI-II ((Beck Depression Inventory) ≥14
* The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient unable to give informed consent.
* Participants planning to donate sperm within three months of psilocybin administration
* Positive pregnancy test at inclusion for participants of childbearing age.
* Patient who is pregnant, breastfeeding, or wishing to become pregnant during participation in the study.
* Any use of classical psychedelic in the last year
* Other current substance use disorder (except tobacco)
* Diagnosed schizophrenic or bipolar disorder
* High emotional lability (clinician-judged)
* On antipsychotics treatment that may interfere with psilocybin.
* Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.
* Severe suicidal ideation (high risk on the Columbia scale)
* 1st degree family member with a diagnosed psychotic disorder
* Severe cognitive impairment (clinician-judged)
* CIWA-AR \> 8
* Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc \> 470 ms for women and \>450 ms for men); heart failure; uncontrolled hypertension (greater than 165/95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.

Where it's running

• CHU de Nîmes
  Nîmes, France Recruiting
• Centre Hospitalier de la Côte Basque
  Bayonne, France Not yet recruiting
• CHU Besançon
  Besançon, France Not yet recruiting
• CHU de Bordeaux
  Bordeaux, France Not yet recruiting
• CHU Brest
  Brest, France Not yet recruiting
• CH Le Vinatier
  Bron, France Not yet recruiting

Study contacts

• Principal investigator: Amandine Luquiens — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Amandine Luquiens
• Email: amandine.luquiens@chu-nimes.fr
• Phone: 04.66.68.69.98

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.