New Phase 3 psilocybin trial in France targets relapse prevention in alcohol use disorder
A new Phase 3 clinical trial has started in Europe to evaluate psilocybin for relapse prevention in people with severe alcohol use disorder and depressive symptoms following detoxification. The ERPPAD trial is sponsored by the Centre Hospitalier Universitaire de Nîmes and will be conducted in France, making it a fully European Phase 3 study, although taking place in one country.
The study addresses an important clinical gap. Alcohol use disorder is often accompanied by depressive symptoms, which can increase the risk of early relapse after detoxification. According to the trial description, up to 40% of people with alcohol use disorder experience depression, and no treatment is specifically approved for people living with both alcohol use disorder and depression.
The trial plans to enrol 172 adults with severe alcohol use disorder and depressive symptoms. Participants will receive psilocybin-assisted psychotherapy and be randomised to either two high-dose psilocybin sessions or two low-dose psilocybin sessions, administered three weeks apart. The main objective is to assess whether the high-dose approach is more effective in preventing relapse over a six-month period.
The study builds on earlier French pilot work in this area. The PAD pilot study explored psilocybin-assisted psychotherapy in people recently detoxified from alcohol and living with depressive symptoms, providing feasibility and acceptability data as well as preliminary efficacy signals. The ERPPAD trial now takes this work into a larger, later-stage clinical setting.
This is a notable development for Europe’s psychedelic research landscape. Most attention around late-stage psychedelic trials has focused on depression and PTSD, often led by companies and largely outside continental Europe. A Phase 3 academic trial in France focused on alcohol use disorder and depressive symptoms shows that European clinical research can also move into advanced stages of development in complex mental health and addiction indications.
