RECRUITING Phase 2 ClinicalTrials.gov

Subjective Experience Following Psilocybin

Sponsor: University of Calgary • ClinicalTrials.gov ID: NCT06768944

Registry updated: 2026-09-02

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Description

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.

Interventions

Psilocybin high-dose (Drug)
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
Psilocybin low-dose (Drug)
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.
Risperidone 1 MG (Drug)
risperidone 1mg capsules
Placebo (Drug)
inactive placebo

Eligibility criteria

Inclusion Criteria: * Individuals of all sexes, gender identities, and ethnicities * Ages 18 to 65 years of age at the time of screening * Ability to read/write in English * Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation Exclusion Criteria: * Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests * Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, moderate to severe substance use disorders, eating disorders, personality disorders, post-traumatic stress disorder * Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder * Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II * Medication: Any medication with the potential to interact with the investigational medicinal products, especially those with serotonergic mechanisms of actions like SSRIs, SNRIs or MAO-Inhibitors as well as other antipsychotics * Currently pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study * Current or recent (within 12 weeks) participation in a clinical trial involving medication administration * Cognitive impairment (Folsetin Mini Mental State Exam score \< 24) * A disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). * Suffered a traumatic brain injury with one of the following symptoms Loss of consciousness \>30min Alteration of consciousness/mental state \>24h Post-traumatic amnesia \>1 day Glasgow Coma Scale (best available score in first 24 hours) \<13 * Any other circumstances that, in the opinion of the investigators, compromises participant safety

Conditions

Investigating the Importance of the Subjective Psychedelic Experience

Locations

University of Calgary — Calgary, Alberta, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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