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Subjective Experience Following Psilocybin

NCT06768944 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Investigating the Importance of the Subjective Psychedelic Experience

Interventions

DRUG

Psilocybin low-dose

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.

DRUG

Risperidone 1 MG

risperidone 1mg capsules

DRUG

Placebo

inactive placebo

DRUG

Psilocybin high-dose

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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Leah Mayo, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768944 on ClinicalTrials.gov