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Psychedelic therapy aims to break the relapse cycle in alcoholism and depression

NCT ID NCT07638553

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 4 times

Summary

This phase 3 trial investigates whether high-dose psilocybin, given alongside psychotherapy, can prevent relapse in people with severe alcohol use disorder who also have depressive symptoms. Participants receive either a high dose (25 mg) or a low dose (3 mg) of psilocybin in two sessions three weeks apart. The study measures relapse rates and time to relapse over six months, building on promising pilot results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin
What this could lead to
If successful, this could offer a new, fast-acting treatment option for people with both alcohol use disorder and depression, helping them stay sober longer.
What could go wrong
This is a phase 3 trial, but results may not apply to everyone. Psilocybin can cause intense psychological effects, and the therapy requires careful supervision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Le Vinatier

    NOT_YET_RECRUITING

    Bron, France

  • CHU Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • CHU Brest

    NOT_YET_RECRUITING

    Brest, France

  • CHU Saint-Etienne

    NOT_YET_RECRUITING

    Saint-Priest, France

  • CHU de Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30029, France

  • Centre Hospitalier de la Côte Basque

    NOT_YET_RECRUITING

    Bayonne, France

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