NCT05317689

Comparing the Effects of Psilocin and Psilocybin in Healthy Adults

Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.

Detailed description

The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Psilocin	17.5mg oral psilocin with psychological support and physiological monitoring
DRUG	Psilocybin	25mg oral psilocybin with psychological support and physiological monitoring
DRUG	Sublingual Psilocin	2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring

Timeline

• Start date: 2022-05-26
• Primary completion: 2025-01-16
• Completion: 2025-07-01
• First posted: 2022-04-08
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study