Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder
Phase I, non-randomised, sequential 3-session psilocybin-assisted psychotherapy study (n=30) using 3+3 dose-escalation sequences (doses 15→45 mg) to evaluate safety, tolerability, and preliminary efficacy for PTSD.
Details
This Phase I, non-randomised sequential trial will enrol up to 30 participants with PTSD to receive psilocybin-assisted psychotherapy across three dosing sessions approximately two weeks apart. A 3+3 dose-escalation framework evaluates predefined dose sequences ranging from 15 mg to 45 mg.
Safety and tolerability will be assessed after each session and at 1-month, 3-month, and 6-month follow-ups; efficacy endpoints include change in PTSD symptom severity measured by clinician- and self-report instruments.
Key exclusions include current suicidality, psychotic or bipolar I disorder, significant cardiovascular or neurologic illness, and recent or extensive hallucinogen use.