Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD (SUN004)

This Phase 2, single-center, fixed-dose, open-label study evaluates a single 25 mg oral psilocybin dose administered with preparatory and integration psychotherapy in cisgender women with PTSD following sexual assault (n=35).

Primary aims are efficacy, safety, and tolerability; key entry criteria include CAPS-5 ≥25, stable SSRI use permitted, negative pregnancy test and contraception requirements, and exclusion for significant suicidal risk or psychotic/bipolar disorders.