Recruiting

Phase 2

Psilocybin with RisperidoneSubjective Experience Following Psilocybin

Sponsor:

University of Calgary

Code:

NCT06768944

Conditions

Investigating the Importance of the Subjective Psychedelic Experience

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Psilocybin high-dose

Psilocybin low-dose

Risperidone 1 MG

Placebo

Study Details

Brief 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

Study ID

NCT06768944

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: High-dose psilocybin + placebo

placebo + psilocybin (+60 min)

active comparator: Low-dose psilocybin + placebo

placebo + psilocybin (+60 min)

experimental: High-dose psilocybin + risperidone

risperidone + psilocybin (+60 min)

active comparator: Low-dose psilocybin + risperidone

risperidone + psilocybin (+60 min)

Interventions

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

Psilocybin low-dose

Risperidone 1 MG

risperidone 1mg capsules

Placebo

inactive placebo

Primary outcome measure

Positive effects [ Time Frame: One week and one month post-dosing ]

Central Contacts and Locations

Central contacts

Ana Deutsch, MSc

587-893-0257 septrial@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Ana Deutsch, MSc

587-893-0257 septrial@ucalgary.ca

Principal Investigator:

Leah Mayo, PhD

More Information

Sponsor

University of Calgary

Last update posted

Sep 2, 2026

Last verified

May, 2026

Keywords

psychedelics
psilocybin
stress response
cortisol
healthy participants
risperidone
subjective effects

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-09-02.