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Psychedelic

Safety, Tolerability, and Treatment for Anorexia Nervosa

Phase 2
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 1, day 7, and day 28
Awards & highlights

Study Summary

This study is evaluating whether a single dose of psilocybin may help reduce symptoms of anorexia nervosa.

Eligible Conditions
  • Anorexia Nervosa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 1, day 7, and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 1, day 7, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and occurrence of changes in AEs
Incidence of changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) at each post-Baseline visit
Incidence of clinically important changes in ECG parameters
+2 more
Secondary outcome measures
Change in Body Image State Scale (BISS) total score
Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern
Change in Eating Disorder Examination Questionnaire Short Form (EDE-QS) total scores
+5 more
Other outcome measures
Change in Clinical Impairment Assessment (CIA) total scores
Change in Eating Disorder readiness to change and motivation for change (ED-RR)
Change in Quick Inventory of Depressive Symptomatology (QIDS) total score
+4 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Safety, Tolerability, and TreatmentExperimental Treatment1 Intervention
On dosing day, each participant will receive 1 x 25 mg treatment bottle containing 5 x 5 mg oral capsules of psilocybin. The administration session will last approximately 4-6 hours and will be supported by a lead therapist and an assisting therapist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,391 Total Patients Enrolled
15 Trials studying Anorexia Nervosa
1,598 Patients Enrolled for Anorexia Nervosa
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,542 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
60 Patients Enrolled for Anorexia Nervosa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Arizona
California
How old are they?
18 - 65
What site did they apply to?
Altman Clinical and Translational Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
Walter Kaye 2021. "Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661514.
~4 spots leftby Apr 2025
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