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NCT06399263 · ClinicalTrials.gov registry record · Phase 2
Study of Psilocybin for Anorexia in Young Adults
A Phase 2 study of Anorexia Nervosa, sponsored by Marissa Raymond-Flesch, MD, MPH.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT06399263: Recruiting Phase 2 study of Anorexia Nervosa, sponsored by Marissa Raymond-Flesch, MD, MPH.
NCT06399263 is a Phase 2 study of Anorexia Nervosa that is actively recruiting participants, run by Marissa Raymond-Flesch, MD, MPH. The registered enrollment target is 40 participants, below the 949-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06399263, a Phase 2 study of Anorexia Nervosa, is actively recruiting participants, sponsored by Marissa Raymond-Flesch, MD, MPH.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The EDE assess eating disorder behaviors and attitudes though an interviewer administered questionnaire. It provides 4 subscale scores (Restraint, Eating Concern, Shape Concern and Weight Concern). Score range from 0 to 6 and are averaged to calculate a global score. Higher scores indicate increased eating disorder thoughts and behaviors.
Conditions Studied
Interventions
- DRUG Psilocybin
- BEHAVIORAL Preparation and Integration Sessions
Study Locations (2)
California
- University of California, San Francisco - San Francisco
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2029-11 |
| Phase | Phase 2 |
What NCT06399263 shows while recruiting
NCT06399263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 949-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Anorexia Nervosa appearing as the primary indexed condition, and to 2 interventions - of which Psilocybin is the first listed.
NCT06399263 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06399263 about?
NCT06399263 is a clinical study titled "Study of Psilocybin for Anorexia in Young Adults". 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 fi...
What is the current status of trial NCT06399263?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-11-18. Estimated completion is 2029-11.
What conditions does trial NCT06399263 study?
This clinical trial studies the following conditions: Anorexia Nervosa.
What interventions are being tested in trial NCT06399263?
The interventions under investigation include: Psilocybin (DRUG), Preparation and Integration Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT06399263?
This trial is sponsored by Marissa Raymond-Flesch, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06399263 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anorexia Nervosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06399263's enrollment target sits among peer trials
40 23rd of 43 higher than 18 of 43 other Anorexia Nervosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anorexia Nervosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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