Single-group, single-blind Phase I interventional study (n=30) of psilocybin-assisted psychotherapy with three oral dosing sessions (1 mg then 25 mg ×2) given every two weeks in adults with treatment-resistant anorexia nervosa.
Open single-group Phase I study delivering three psilocybin dosing sessions integrated with structured psychotherapy. Preparatory contact includes at least one face-to-face and one telehealth session (total ~6–8 hours) before first dose; dosing sessions last approximately 6–8 hours and are supervised by clinical staff.
Dosing schedule: session 1 = 1 mg, sessions 2 and 3 = 25 mg each, spaced two weeks apart; participant is blinded to dose. Outcomes include change in core eating-disorder psychopathology (EDE/EDE‑Q), depression (BDI‑II), with baseline, 6‑week post‑first dose, monthly to 6 months and 12‑month follow-up assessments.
Three oral psilocybin dosing sessions integrated with preparatory and integration psychotherapy; participant single-blind to dose.
Session doses: 1 mg (session 1), 25 mg (sessions 2 and 3); participant blinded to dose; psychotherapy provided; administered by nurse practitioner and clinical psychologist.