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RecruitingPhase 2

Subjective Experience Following Psilocybin

NCT06768944 · SEP-1 · University of Calgary

Recruiting
Status
Accepting participants
Phase 2
Phase
128
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Positive effects

    Measured over One week and one month post-dosing

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University of CalgaryCalgaryAlbertaCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06768944 on ClinicalTrials.gov →

Last updated in the registry 2026-06-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits