Who Qualifies for Treatment?

• Age: between 21 and 80 years old

• Has or has had a cancer diagnosis that is potentially life-threatening. Patients with an active cancer (e.g. stage III or IV with a poor prognosis) or disease progression or recurrence are eligible. Patients who do not have an active cancer or disease progression or disease recurrence are only eligible if at least 1 year has elapsed since their diagnosis.

• Have an ECOG performance status of 0, 1, or 2.

• Patients receiving chemotherapy, hormonal therapy, radiation therapy, biologic therapies may participate while receiving those therapies. Continuing hormonal therapy, chemotherapy, or radiation treatment is acceptable if the patient is tolerating the therapy or treatment in a sufficient fashion to allow administration of oral psilocybin.

• Agree that for one week preceding each psilocybin session, he/she will refrain from taking any
  • non-prescription medication,
  • nutritional supplement, or
  • herbal supplement except when approved by the treatment team.

Exceptions will be evaluated by the treatment team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

• Agree not to use nicotine for at least 2 hours before psilocybin administration, and not again until questionnaires have been completed approximately 7 hours after psilocybin administration.

• Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on psilocybin session days.

• Agree not to take any PRN medications on the mornings of psilocybin sessions, with the exception of daily opioid pain medication. Non-routine PRN 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.

• 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, nicotine, and opioid pain medication.

• NO cancer with known CNS involvement, or other major CNS disease. In addition to diagnostic results provided by the referring physician, patients will undergo a neurological exam at the study site. No evidence of a focal deficit.

• NOT in treatment in another clinical trial involving an investigational product for treatment of cancer.

• No hepatic dysfunction as indicated by the following values:

— GGT > 3 x ULN (upper limit of norm)

— AST > 3 x ULN

— ALT > 3 x ULN

— Tot Bili > 3.0 mg/dl

• No known paraneoplastic syndrome or “ectopic” hormone production by the primary tumor such as the patient could have or be at risk for hypercalcemia, Cushing’s syndrome, hypoglycemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome

• No Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrilation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)

• No blood pressure exceeding 140 systolic or 90 diastolic

• No epilepsy with history of seizures

• No renal insufficiency (creatinine clearance < 40 ml/min using the Cockraft and Gault equation)

• No Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia

• Females who are NOT pregnant (positive pregnancy test) or nursing, or are practicing an effective means of birth control

• NOT currently taking on a regular (e.g., daily) basis:
  • investigational agents,
  • psychoactive prescription medications (e.g., benzodiazepines),
  • medications having a primary pharmacological effect on serotonin neurons (e.g., odansetron), or
  • medications that are MAO inhibitors.

For individuals who have intermittent or PRN use of investigational agents, psychoactive prescription medications, medications having a primary pharmacological effect on serotonin neurons, or medications that are MAO inhibitors, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.

• Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release — which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.

• NOT currently using any the following of potent metabolic inducers or inhibitors:

Inducers – Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, Taxol, dexamethasone), St Johns Wort; Inhibitors – all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.

• No medical requirement that patient receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.