Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

You may not be if

• Have given written informed consent
• Read, write, and speak English
• At Screening, meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a symptom duration of 6 months or longer according to the Clinician-Administered PTSD Scale for DSM-5
• Able to complete the study measures
• Previously sought treatment for PTSD (e.g., prolonged exposure therapy, cognitive processing therapy, sertraline, paroxetine)
• 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 beta-human chorionic gonadotropin, urine toxicology screen).
• Current physical dependence (as evidenced by self-reported withdrawal symptoms) on a drug other than caffeine or nicotine
• Seizure disorder
• Receiving current treatment for PTSD
• Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval \>450msec), transient ischemic attack (TIA) in the last 6 months, stroke, or uncontrolled hypertension with resting blood pressure systolic \>150 or diastolic \>95.
• Recent (\<1year) intracranial or subarachnoid hemorrhage, ischemic stroke, TIA
• Pulmonary disease: chronic obstructive pulmonary disease, active asthma (inhaler use in last 6 months)
• Diabetes mellitus treated with insulin or oral hypoglycemic agents
• Current suicidal ideation or suicidality
• Current engagement in evidence-based PTSD therapy/treatment (prior to psilocybin session)
• Women: Pregnancy (pregnancy tests will be conducted for women during screen and prior to experimental sessions).
• Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
• Currently taking efavirenz or serotonin-acting dietary supplements (e.g., 5-hydroxy- tryptophan, St. John's wort).
• Currently taking antidepressants of any drug class, antipsychotics, or monoamine oxidase inhibitors.
• Recent (within past 12 months) or extensive history of hallucinogen use (\>20 lifetime uses).
• Moderate or severe DSM-5 Substance Use Disorder in the past five years (excluding tobacco and caffeine)
• Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
• For the final (5th) dose sequence (35, 40, and 45 mg) participants that weigh less than 50 kg