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About
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
Full description
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes.
An earlier study that was done in our lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. This study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 80 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion criteria
Volunteers must:
Exclusion criteria
General Medical Exclusion Criteria
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 performed by our BPRU internist. Any patient with evidence of a focal deficit will be excluded.
Hepatic dysfunction as indicated by the following values:
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
Cardiovascular conditions: 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)
Blood pressure exceeding screening criteria described below
Epilepsy with history of seizures
Renal disease (creatinine clearance < 40 ml/min using the Cockcroft and Gault equation)
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
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., ondansetron), or medications that are MAO inhibitors. 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.
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.
In addition to the foregoing, patients will be excluded if they are 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.
In addition to the foregoing, patients will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
Psychiatric Exclusion Criteria
Cardiovascular screening:
There will be at least four blood pressure assessment occasions over at least two separate days. Within a day, assessment occasions will be separated by at least 15 minutes. Each assessment occasion will involve two or more blood pressure readings. To qualify for the study, the mean blood pressure (mm Hg) of the four or more assessment occasions will not exceed 140 systolic and 90 diastolic.
Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes. As recommended by the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, these assessments will involve the average of 2 or more readings separated by two minutes. If the first 2 readings differ by more than 5 mm Hg, additional readings will be obtained and averaged. On one or more of the blood pressure measurement occasions, the volunteer will be acclimated to the automated blood pressure monitoring equipment by repeatedly taking blood pressure (at least 3 readings) with the device. Because it has been our experience that time-to-time blood pressure readings with the automated equipment can be variable due to measurement artifact, any reading that initially exceeds our threshold value will be reassessed twice within 4 minutes to assure accuracy.
Primary purpose
Allocation
Interventional model
Masking
56 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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