Actively Recruiting
Study of Psilocybin for Anorexia in Young Adults
Led by Marissa Raymond-Flesch, MD, MPH · Updated on 2026-03-03
40
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Psilocybin for Anorexia in Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Between 18 and 25 years old at time of screening
- Meets DSM-5 criteria for any type of Anorexia Nervosa
- Currently experiencing symptoms of Anorexia Nervosa
- Comfortable reading and writing in English
- No anticipated changes in medication or surgical procedures during trial
- Commit to attend all in-person and remote study visits and participate in data collection
- Able to identify one or two family members or close friends to co-enroll and participate in select therapy sessions
- Agree to use a highly effective form of contraception two weeks before and one month after the study
- Agree to refrain from nonprescription medications, supplements, or herbal supplements for one week before each psilocybin session, except approved exceptions
- Agree to consume usual amounts of caffeine before psilocybin dosing sessions or abstain if not a regular consumer
You will not qualify if you...
- Current known pregnancy or positive pregnancy test at any time during the study
- Personal history of bipolar disorder or psychotic disorder verified by clinical interview
- Body Mass Index less than 12 at screening
- Unstable vital signs including blood pressure, heart rate, or temperature
- Abnormal safety laboratory results
- Electrocardiogram abnormalities
- Hospitalization or residential program participation for more than 2 of the past 4 weeks at screening
- Unwillingness to abstain from alcohol, CBD, THC, marijuana, illicit drugs for 48 hours pre and post psilocybin dosing and nicotine for 10 hours pre and post dosing
- Positive urine toxicology for specified substances on dosing days
- History of cardiovascular disease
- Uncontrolled endocrine conditions including diabetes and thyroid disorders
- Significant and uncontrolled gastrointestinal or neurological illness
- Use of prohibited medications or inability to discontinue per study protocol
- Needle phobia
- Enrollment in another clinical trial
- Pregnant or breastfeeding
- Allergy or intolerance to study drug materials
- History of severe reaction to psychedelics
- High risk of self-harm or suicide
- Mental health conditions preventing treatment engagement
- Unable or unwilling to participate fully including hydration requirements on dosing days
- Any safety concerns as determined by study physicians
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94107
Not Yet Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
L
Lisa Fredenburg, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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