Name (first, middle, and last)
* must provide value
Email address
* must provide value
Phone number
* must provide value
How did you hear about the trial?
* must provide value
Date of Birth (Month/Year)
* must provide value
Gender
* must provide value
Male
Female
Non-binary/other
High school level of education
* must provide value
Yes
No
Are you fluent in speaking and reading the predominantly used or recognized language of the study site (i.e., English)
* must provide value
Yes
No
Male or Female, age ≥ 18 to 65 years old at the time of signing the informed consent.
* must provide value
Yes
No
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
* must provide value
Yes
No
Have you had a persistent low mood nearly every day for at least two years?
* must provide value
Yes
No
Have you been diagnosed and/or treated for Major Depressive Disorder (depression) in the last two years?
* must provide value
Yes
No
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.)
* must provide value
Yes
No
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.
* must provide value
Yes
No
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.
* must provide value
Yes
No
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.
* must provide value
Yes
No
Have you or will you have participated in another investigational study within the 60 days prior to the screening visit?
* must provide value
Yes
No
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)?
* must provide value
Yes
No
Blood pressure exceeding screening criteria described below:
Cardiovascular screening At the screening and randomization visit, blood pressure will be assessed to qualify to proceed in the trial. Each assessment occasion will involve two or more blood pressure readings. To qualify for the study, the mean blood pressure (mmHg) of the two readings will not exceed 140 systolic and 90 diastolic.
* must provide value
Yes
No
Do you have epilepsy with history of seizures?
* must provide value
Yes
No
Do you have a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation?
* must provide value
Yes
No
Do you have a clinically significant history of head injury or head trauma?
* must provide value
Yes
No
Do you have a history of cancer?
* must provide value
Yes
No
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?
* must provide value
Yes
No
Do you have insulin-dependent diabetes or a history of hypoglycemia?
* must provide value
Yes
No
Are you pregnant, nursing or are of childbearing potential and are not practicing an effective means of birth control?
* must provide value
Yes
No
N/A
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?
* must provide value
Yes
No
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
* must provide value
Yes
No
Have you used steroids in the past two weeks?
* must provide value
Yes
No
Have you used ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl within the past two weeks?
* must provide value
Yes
No
Do you agree to refrain from using any psychoactive drugs, including alcoholic beverages within 24 hours of each drug administration? The exception is caffeine.
* must provide value
Yes
No
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?
* must provide value
Yes
No
Do you agree to refrain from starting any new medications?
* must provide value
Yes
No
Do you agree to refrain from starting any new complementary or alternative medicine practices (e.g., nutrition/diet modifications, supplements, meditation practice, etc.)?
* must provide value
Yes
No
Are you willing to comply with medication requirements per the protocol?
* must provide value
Yes
No
Do you agree to refrain from working night shifts?
* must provide value
Yes
No
Have you had a previous negative experience with any psychedelic substance?
* must provide value
Yes
No
Do you have a sensitivity to maltodextrin?
* must provide value
Yes
No
Do you have a current or past history of meeting DSM-V criteria for Schizophrenia, Psychotic Disorder, or Bipolar I or II Disorder?
* must provide value
Yes
No
Do you have Active Major Depressive Disorder Episodes?
* must provide value
Yes
No
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?
* must provide value
Yes
No
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?
* must provide value
Yes
No
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)?
* must provide value
Yes
No
Have you used psychedelics within the past six months? (Psilocybin mushrooms, LSD, or mescaline. Does not include MDMA, ketamine, or cannabis.)
* must provide value
Yes
No
Smoking status
* must provide value
Never smoked
Previous smoker
Current smoker
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Approximate years of smoking
* must provide value
Average number/day
* must provide value
Average number of cups of coffee per day
* must provide value
Time usually taken
* must provide value
Now H:M
Do you have a history of suicidal ideation?
* must provide value
Yes
No
Have you ever been hospitalized for your depression?
* must provide value
Yes
No
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
* must provide value
Please rate the severity of your depression on a scale of 1 to 10
* must provide value
Signature
* must provide value
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