NCT06399263

Study of Psilocybin for Anorexia in Young Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Marissa Raymond-Flesch, MD, MPH · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be measured pre and post treatment. One to two family member(s) of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DRUG	Psilocybin	The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg.
BEHAVIORAL	Preparation and Integration Sessions	The psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions.

Timeline

• Start date: 2024-11-18
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2024-05-03
• Last updated: 2026-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study