Bioavailability Study of Psilocybin in Normal Adults

This open-label Phase I study (n=8) will compare the bioavailability of IV and oral psilocybin (5mg vs 25mg). It is expected to yield similar pharmacokinetic and psychedelic (subjective) effects, but more consistent blood levels for IV.

Topic Healthy Subjects
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published
Start date 01 October 2022
End date 01 June 2023
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 8
Sex All
Age 18- 99
Therapy No

Trial Details

The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks. Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.

NCT Number NCT05467761

Sponsors & Collaborators

University of Wisconsin-Madison
The Transdisciplinary Center for Research in Psychoactive Substances (TCRPS) was launched at the University of Wisconsin-Madison in 2021.

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

Data attribution

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