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NOT YET RECRUITING
NCT06768944
PHASE2

Subjective Experience Following Psilocybin

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.

Official title: The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2026-04

Completion Date

2028-01

Last Updated

2026-02-06

Healthy Volunteers

Yes

Interventions

DRUG

Psilocybin 25 mg

The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose (25mg)

DRUG

Psilocybin 1 mg

The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose (1mg)

DRUG

Risperidone 1 MG

risperidone 1mg capsules

DRUG

Placebo

inactive placebo

Locations (1)

University of Calgary

Calgary, Alberta, Canada