See if the psychedelic experience matters for psilocybin’s effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial investigates the role of the acute subjective psychedelic experience in psilocybin’s effects by comparing high and low psilocybin doses with either placebo or risperidone pretreatment. It will measure self-reported well-being, mood, and anxiety, along with biological markers such as cortisol and BDNF, plus cognitive flexibility and stress responses. The study uses randomization, baseline screening, and follow-up assessments including questionnaires and biomarker tests to explore acute (day of dosing) and protracted (one week later) outcomes. Participants are healthy adults aged 18-65 without psychiatric diagnoses and must meet safety criteria before dosing at a single site (University of Calgary).

Why it matters

Who can join: the full rules

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 it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Leah Mayo, PhD — University of Calgary
• Study coordinator: Ana Deutsch, MSc
• Email: septrial@ucalgary.ca
• Phone: 587-893-0257

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.