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Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms
Sponsor: Centre Hospitalier Universitaire de Nīmes
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
Psilocybin (high dose)
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
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