NCT05467761

Bioavailability Study of Psilocybin in Normal Adults

A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oral Psilocybin	25mg orally
DRUG	IV Psilocybin	5mg intravenously

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-07-20
• Last updated: 2023-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study