A Phase 1, Open-label, Pilot Study to Assess the Safety, Feasibility and Initial Efficacy of IV infused Psilocin (TRP-8803) Administration in Concert with Psychotherapy Among Adult Patients with Binge Eating Disorder (BED)
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).
Details
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.