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Study identifier: NCT07638553 Synced from ClinicalTrials.gov · July 30, 2026
● Recruiting

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

Condition: Alcohol Use Disorder · Depressive Sympotoms · Psilocybin  ·  Sponsor: Centre Hospitalier Universitaire de Nīmes

PhasePhase 3
Planned participants172
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Amandine Luquiens  ·  04.66.68.69.98  ·  amandine.luquiens@chu-nimes.fr

Always discuss trial participation with your own doctor first.

Locations (8)

Centre Hospitalier de la Côte BasqueBayonne, FranceNot Yet Recruiting
CHU BesançonBesançon, FranceNot Yet Recruiting
CHU de BordeauxBordeaux, FranceNot Yet Recruiting
CHU BrestBrest, FranceNot Yet Recruiting
CH Le VinatierBron, FranceNot Yet Recruiting
CHU de NantesNantes, FranceNot Yet Recruiting
CHU de NîmesNîmes, FranceRecruiting
CHU Saint-EtienneSaint-Priest, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07638553