UW Psilocybin Pharmacokinetics Study

The primary objective of this clinical trial is to determine the pharmacokinetics of an extemporaneous oral formulation of psilocybin in normal, healthy adults. This study is intended to add to the existing body of modern clinical research on psilocybin to support future multi-institutional Phase III clinical trials seeking to decrease anxiety and depression in patients with incurable cancer. The long-term goal of this research is to submit a successful new drug application for psilocybin to the FDA.

Subjects will initially take one 0.3 mg/kg (approximately 20mg/70kg) oral dose of psilocybin to initiate an eight hour chaperoned outpatient experience. After eight hours of outpatient sampling, the subject will be transported across the street to the UW Institute for Clinical and Translational Research Clinical Research Unit (ICTR CRU) for an overnight stay and additional blood and urine sampling. Pre- and post-treatment psychologic preparation and debriefing interviews will be required.

A minimum of four weeks after the first dose, the subject will receive a second oral dose of psilocybin at the higher dose of 0.45 mg/kg (approximately 30 mg/70 kg). This dosing will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours). A minimum of four weeks after the second dose, the subject will receive a third oral dose of psilocybin at the highest dose of 0.6 mg/kg (approximately 40 mg/70 kg). This dose will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours).

12-lead ECGs will be obtained at specified time points before and during each treatment period. Throughout the duration of drug action for each dose participants will be attended by two trained monitors, and a physician will available during the entire 24 hour treatment and sampling period.

Subjects who have been administered the first dose but decline to receive any subsequent doses will remain evaluable. At that time their active study participation will end.