Study of Psilocybin for Anorexia in Young Adults

Part of paid clinical trials in San Francisco, California.

Sponsor
Marissa Raymond-Flesch, MD, MPH
Study ID
NCT06399263
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Jan 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin Therapy
    The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and four final integration sessions

Primary Outcome Measure

Eating Disorder Examination (EDE) [ Time Frame: Baseline, 28 days, 90 days, 365 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94107
Lisa Fredenburg, MS
[email protected]
Marissa Raymond-Flesch, M.D. (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143-

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