This Phase I open-label trial (n=12) will investigate the safety, feasibility, and initial efficacy of intravenous psilocin (TRP-8803), administered in two doses (ranging from 6.7 mg to 15 mg) two weeks apart, paired with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).
Open-label, non-randomised Phase I study of TRP-8803 (psilocin) administered IV in two sessions two weeks apart with cohort-based staggered dosing (options spanning ~6.7–15 mg total per session) and DSMB safety review between cohorts.
All participants receive a therapist dyad delivering preparatory (3×90 min), dosing support, and integration psychotherapy (multiple 90 min sessions); safety assessed via AEs, vitals, ECG, labs and psychiatric measures.
Open-label single-arm administration of intravenous TRP-8803 (psilocin) with preparatory and integration psychotherapy; two dosing sessions two weeks apart; cohort-based staggered dosing with multiple infusion regimens (6.7–15 mg).
Infusion regimens include Option A (LD 5 mg/20 min + MD 6.7 mg/40 min; ~60 min), Option B (LD 5 mg/20 min + MD 10 mg/240 min; ~260 min), Option C (LD 8 mg/30 min + MD 7 mg/120 min; ~150 min). Cohort escalation and DSMB review between cohorts.