UW Psilocybin Pharmacokinetics Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of
      mushrooms, collectively known as psilocybin mushrooms. Psilocybin
      (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first
      isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to
      determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The
      study is performed in support of Phase II and Phase III studies of psilocybin for the
      treatment of refractory anxiety associated with incurable cancer, as well as other possible
      indications. Psilocybin is at present not an FDA-approved drug.
    

Detailed description: 
      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.
    

Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Dose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg)
Intervention MeSH terms: Psilocybin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psilocybin; Pharmacokinetics