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Psychedelic

Psilocybin for Anorexia Nervosa

Phase 1
Waitlist Available
Led By Roland Griffiths, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post final psilocybin session
Awards & highlights

Study Summary

This trial will study whether psilocybin is safe and effective in people with anorexia nervosa. Psilocybin has been shown to decrease depression and anxiety in other populations, and the investigators hope to see similar changes in people with anorexia.

Eligible Conditions
  • Anorexia Nervosa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post final psilocybin session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post final psilocybin session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hospital Anxiety and Depression Scale (HADS) Score
Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS)
Secondary outcome measures
Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score
Change in Body mass index (BMI)
Change in Eating Disorder Examination (EDE) score
+1 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: Experimental psilocybinExperimental Treatment1 Intervention
Participants will have up to four doses of psilocybin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,142 Total Patients Enrolled
3 Trials studying Anorexia Nervosa
179 Patients Enrolled for Anorexia Nervosa
Roland Griffiths, Ph.D.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

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

Does the age limit for this experiment extend past 75 years old?

"According to the age requirements set out in this study, anyone 18 or older but not yet 65 years old may enroll."

Answered by AI

What risks do patients face when taking Psilocybin?

"Psilocybin's safety is based on limited data, as this is a Phase 1 trial. Therefore, it received a score of 1 from our team at Power."

Answered by AI

Why did researchers design this clinical trial?

"The primary outcome of this clinical trial, which will be measured over a 1 week post final psilocybin session time frame is to Change in health related quality of life as assessed by the Eating disorder Quality of Life Scale (EDQLS). Secondary outcomes include Change in Body mass index (BMI) which is defined as This is a measure of body mass calculated from height and weight (Kg/m^2)., Change in Eating Disorder Examination Questionnaire (EDE-Q) score which is defined as This is a 28-item self-report score that measures severity of eating disorder symptoms across four domains that each"

Answered by AI

Are new participants still being welcomed into this experiment?

"As seen on clinicaltrials.gov, this particular study is not currently looking for new patients to enroll. The trial was first posted on August 26th, 2019 and updated most recently on August 19th, 2022. Although this study isn't recruiting now, there are 116 other active trials that might be a match for potential participants."

Answered by AI

Have researchers previously looked into the effects of Psilocybin on patients?

"0 Psilocybin clinical trials are in Phase 3, with 37 total active Psilocybin clinical trials. Most of these studies are based out of Vancouver, Washington, but there are 40 research sites in total."

Answered by AI

How many research subjects are included in the total sample size for this investigation?

"This particular study is no longer recruiting patients. It was initially posted on August 8th, 2019 but the most recent update occurred on August 19th, 2020. However, there are currently 79 other clinical trials related to anorexia nervosa and 37 involving psilocybin that are actively looking for participants."

Answered by AI

For whom is this clinical trial designed?

"The applicants for this trial must suffer from anorexia nervosa and be ages 18-65. Around 18 people will be accepted into the study."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Rhode Island
Indiana
Other
How old are they?
18 - 65
What site did they apply to?
Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~4 spots leftby Apr 2025