Status:
COMPLETED
Effects of Psilocybin in Anorexia Nervosa
Lead Sponsor:
Johns Hopkins University
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression...
Eligibility Criteria
Inclusion
- General
- Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and have a history of AN for at least 3 years prior to screening
- Have at least one prior attempt at treatment
- Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (complete blood count, comprehensive metabolic panel, urine pregnancy test, urine toxicology screen).
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
- General
Exclusion
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve, or transient ischemic attack in the past year. Resting heart rate may be no less than 50 beats per minute unless cleared by a cardiologist.
- Epilepsy with history of seizures
- Type 1 diabetes
- First degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
- Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04052568
Start Date
August 26 2019
End Date
April 20 2023
Last Update
May 6 2023
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224