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RECRUITING
NCT07638553
PHASE3

Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

Summary

Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants. The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \[0.16-1.65\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2026-06-30

Completion Date

2030-06

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DRUG

Psilocybin (high dose)

2 administrations of high-dose psilocybin (25 mg) 3 weeks apart

DRUG

Psilocybin (low dose)

2 administrations of low-dose psilocybin (3 mg) 3 weeks apart

Locations (8)

Centre Hospitalier de la Côte Basque

Bayonne, France

CHU Besançon

Besançon, France

CHU de Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CH Le Vinatier

Bron, France

CHU de Nantes

Nantes, France

CHU de Nîmes

Nîmes, France

CHU Saint-Etienne

Saint-Priest, France