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

NCT ID NCT07638553

Recruiting now Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

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

ALCOHOL USE DISORDER DEPRESSIVE SYMPOTOMS PSILOCYBIN

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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