Study of Psilocybin for Anorexia in Young Adults

Exclusion Criteria

• •Current known pregnancy or positive pregnancy test at any time during the study
• •Personal history of bipolar disorder, or psychotic disorder verified by the Structured Clinical Interview for DSM-5 (SCID) and medical history at screening
• •Body Mass Index less than 12 at screening
• •Unstable vital signs including Blood Pressure, Heart Rate, or Temperature
• •Abnormal Safety Labs including sodium, potassium, magnesium, phosphorus, creatinine, estimated Glomerular Filtration Rate, Aspartate Transferase, Alanine Transaminase
• •Electrocardiogram abnormalities
• •Hospitalization or participation in a residential program for more than 2 of the past 4 weeks at the time of screening.
• •Unwilling to abstain from alcohol, Cannabidiol (CBD), tetrahydrocannabinol (THC), marijuana, and illicit drug use for 48 hours pre and post psilocybin dosing days and abstain from nicotine for 10 hours pre and post psilocybin dosing.
• •Positive urine toxicology testing for amphetamines, benzodiazepines, cocaine, cannabis, 3,4-Methylenedioxymethamphetamine (MDMA), and opioids (including methadone and buprenorphine) on the morning of either psilocybin administration session.
• •History of cardiovascular disease
• •Uncontrolled endocrine conditions, including diabetes, hyper or hypothyroidism
• •Significant and uncontrolled gastrointestinal illness at the discretion of the investigator
• •Significant and uncontrolled neurological disease including uncontrolled seizure disorder at the discretion of the investigator
• •Use of any prohibited concomitant medications or inability or unwillingness to discontinue according to the study's prescribed medication taper or tapering with the participants primary prescriber.
• •Needle phobia.
• •Simultaneous enrollment in another clinical trial.
• •Pregnant or Breast feeding.
• •Allergy or intolerance to any of the materials contained in the drug product
• •History of severe reaction to psychedelics at the discretion of the investigators.
• •High risk of self-harm/suicide
• •Mental health condition that will prevent engagement with the treatment team.
• •Unwilling or unable to participate in the treatment protocol as planned, including hydration with sports drinks on dosing days.
• •If any study physician feels that it would be unsafe to continue for any mental, physical or other reason