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Psychedelic Therapy

Psilocybin for Anorexia (SPANYA Trial)

Phase 2

Recruiting

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 28 days, 90 days, 365 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Eating Disorder Examination (EDE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~530

0 / 11Eligibility criteria met