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Psychedelic Therapy

Psilocybin for Anorexia (SPANYA Trial)

Phase 2
Waitlist Available
Led By Marissa Raymond-Flesch, MD
Research Sponsored by Marissa Raymond-Flesch, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets Diagnostic and Statistical Manual (DSM-5) criteria for any type of Anorexia Nervosa
Currently experiencing symptoms of Anorexia Nervosa
Must not have
History of cardiovascular disease
Unwilling or unable to participate in the treatment protocol as planned, including hydration with sports drinks on dosing days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 28 days, 90 days, 365 days
Awards & highlights

Summary

This trial is testing the use of psilocybin therapy to treat severe Anorexia Nervosa in young adults. Participants will have preparatory sessions, two dosing sessions with different amounts of

Who is the study for?
This trial is for young adults with severe Anorexia Nervosa who haven't improved with standard treatments. Participants must have two family members willing to be involved, one of whom will attend certain therapy sessions.
What is being tested?
The study tests psilocybin therapy's effect on Anorexia symptoms in young adults. It includes preparatory and integration sessions, two dosing sessions of psilocybin (20mg then 30mg), and measures changes in eating behaviors.
What are the potential side effects?
Psilocybin may cause temporary effects like mood changes, sensory distortion, confusion, headache, nausea or dizziness. Long-term side effects are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Anorexia Nervosa.
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I am currently experiencing symptoms of Anorexia Nervosa.
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I still have anorexia after trying at least one treatment.
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I am between 18 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart disease.
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I am willing and able to follow the treatment plan, including drinking sports drinks on dosing days.
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My diabetes or thyroid condition is not under control.
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I cannot or do not want to pause my current psychotherapy sessions.
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I am not taking, or can stop taking, any medications not allowed in the study.
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I am extremely afraid of needles.
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My vital signs like blood pressure, heart rate, or temperature are stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 28 days, 90 days, 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 28 days, 90 days, 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Eating Disorder Examination (EDE)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin TherapyExperimental Treatment2 Interventions
The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (30mg), and four final integration sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Marissa Raymond-Flesch, MD, MPHLead Sponsor
Marissa Raymond-Flesch, MDPrincipal InvestigatorUniversity of California, San Francisco
~27 spots leftby Jun 2029
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