Ayahuasca, Esketamine and PTSD

This Phase II, randomized, double‑blind, parallel trial (n=10) will evaluate the effects of a single oral dose of ayahuasca versus oral esketamine in adults with posttraumatic stress disorder (PTSD), with the primary outcome measured by the Posttraumatic Stress Disorder Checklist for DSM-5 from enrolment to the end of treatment at 3 weeks. Adults aged 18 to 65 years meeting criteria for PTSD will be randomised to one of two arms—experimental oral ayahuasca or active‑comparator oral esketamine—each administered as a single dose; participants with psychiatric or other medical comorbidities are excluded. The study is sponsored by the University of Sao Paulo, is due to start on 20 December 2025, and has an estimated completion in July 2026.