Open-label, single-group Phase I pilot (n=22) testing up to four oral psilocybin sessions (initial 20 mg, titratable to 30 mg) in adults with chronic anorexia nervosa to assess safety and preliminary efficacy.
This open-label pilot investigates safety and efficacy of psilocybin administered in a supportive setting with close follow-up in adults with chronic anorexia nervosa; primary aims are safety, reduction in anxiety and depression, and improved quality of life.
Participants may receive up to four moderate-to-high oral psilocybin sessions (first session 20 mg, subsequent sessions may increase by 5 mg to a maximum of 30 mg); outcomes include clinical measures of eating-disorder pathophysiology, mood, and safety assessments.
Up to four moderate-to-high oral psilocybin sessions with dose titration.
First session 20 mg; subsequent sessions may increase by 5 mg increments to max 30 mg.