Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT04052568
Eligibility Criteria:
General Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04052568
Study Brief:
Protocol Section:
NCT04052568