Prescreening Survey

Name (first, middle, and last)

Email address

Phone number

How did you hear about the trial?

Date of Birth (Month/Year)

Age

Gender

Race

Specify

High school level of education

Are you fluent in speaking and reading the predominantly used or recognized language of the study site (i.e., English)

Male or Female, age ≥ 18 to 65 years old at the time of signing the informed consent.

Do you agree to use of a contraceptive method if of childbearing potential? You must have a negative pregnancy test at study entry and must agree to use adequate birth control through 10 days after last treatment session

Have you had a persistent low mood nearly every day for at least two years?

Have you been diagnosed and/or treated for Major Depressive Disorder (depression) in the last two years?

Do you agree that for one week preceding each psilocybin session, you will refrain from taking any nonprescription medication, nutritional supplements, or herbal supplement except when approved by the research team?
(Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals except for SAM-e, 5-HTP, L-tryptophan, and St. John's Wort.)

Do you agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that you consume on a usual morning, before arriving at the research unit on the mornings of psilocybin session days?

Caffeine consumption should not exceed more than ≥600mg/day.

If you do not routinely consume caffeinated beverages, you must agree not to do so on psilocybin session days.

Do you agree not to take any "as needed" medications on the mornings of psilocybin sessions?

Non-routine medications for treating breakthrough pain that were taken in the 24 hours before the psilocybin session may result in rescheduling the treatment session, with the decision at the discretion of the investigators.

Do you agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration?

As described elsewhere, exceptions include daily use of caffeine.

Have you or will you have participated in another investigational study within the 60 days prior to the screening visit?

Have you had any cardiovascular conditions: coronary artery disease, uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)?

Do you have epilepsy with history of seizures?

Do you have a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation?

Do you have a clinically significant history of head injury or head trauma?

Do you have a history of cancer?

Do you have an unstable medical condition such as:

severe renal disease (creatinine clearance < 40 ml/min using the Cockcroft and Gault equation)?

hepatic disease (known history of liver disease, abnormal elevations in LFTs)?

or serious central nervous system pathology?

Do you have insulin-dependent diabetes or a history of hypoglycemia?

Are you pregnant, nursing or are of childbearing potential and are not practicing an effective means of birth control?

Are you currently taking on a regular (e.g., daily) basis any psychotropic medications including investigational agents, psychoactive prescription medications (e.g., benzodiazepines), antidepressants, medications having a primary pharmacological effect on serotonin neurons (e.g., ondansetron), medications that are MAO inhibitors, opioid medications?

Are you currently using of any the following of potent metabolic inducers or inhibitors:

Inducers -Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, Phenobarbital), Nevirapine, Efavirenz, Taxol, Dexamethasone), St John's Wort; All cytochrome P450 Inhibitors - including all HIV protease inhibitors, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, azithromycin, and troleandomycin

Have you used steroids in the past two weeks?

Have you used ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl within the past two weeks?

Do you agree to refrain from using any psychoactive drugs, including alcoholic beverages within 24 hours of each drug administration? The exception is caffeine.

Do you agree to refrain from nicotine use for 2 hours before and at least 7 hours after the initial dose during each treatment session?

Do you agree to refrain from starting any new medications?

Do you agree to refrain from starting any new complementary or alternative medicine practices (e.g., nutrition/diet modifications, supplements, meditation practice, etc.)?

Are you willing to comply with medication requirements per the protocol?

Do you agree to refrain from working night shifts?

Have you had a previous negative experience with any psychedelic substance?

Do you have a sensitivity to maltodextrin?

Do you have a current or past history of meeting DSM-V criteria for Schizophrenia, Psychotic Disorder, or Bipolar I or II Disorder?

Do you have Active Major Depressive Disorder Episodes?

Do you have a first or second-degree relative with schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), or bipolar I or II disorder?

Do you currently meet DSM-V criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin?

Do you have a current or past medical history within the last 5 years of meeting criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)?

Have you used psychedelics within the past six months? (Psilocybin mushrooms, LSD, or mescaline. Does not include MDMA, ketamine, or cannabis.)

Smoking status

Smoking stop date

Approximate years of smoking

Type of tobacco

Average number/day

Average number of cups of coffee per day

Time usually taken

Do you have a history of suicidal ideation?

Have you ever been hospitalized for your depression?

Have you ever used any medication or therapy to treat your depression? If so, list out the medications/forms of therapy. If not, write N/A

Please rate the severity of your depression on a scale of 1 to 10

Signature

Date