Open-label, single-group Phase II trial (n=15) of psilocybin-assisted therapy in US military veterans with PTSD: two oral psilocybin sessions (15 mg then 25 mg) plus preparatory and integration psychotherapy.
Open-label, single-group Phase II treatment study testing psilocybin-assisted therapy for PTSD in US military veterans; target N=15 with two dosing sessions (15 mg then 25 mg) combined with psychotherapy.
Participants complete a 5-week participation phase including three preparatory sessions, two dosing days approximately two weeks apart, and four integration sessions; safety, tolerability, and clinical efficacy (CAPS-5) are primary aims.
Key eligibility: US military veterans with DSM-5 PTSD and CAPS-5 ≥23; exclusions include psychotic/bipolar disorders, significant cardiovascular disease, recent hallucinogen use, and acute suicide risk.
Single-group psilocybin-assisted therapy including 3 preparatory sessions, 2 dosing days (15 mg then 25 mg ~2 weeks apart), and 4 integration sessions over ~5 weeks.
Low-dose first session to assess tolerability and familiarise participants
High-dose second session ~2 weeks after first