Psilocybin for Stress Response (SEP-1 Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByLeah Mayo, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Calgary

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the importance in the acute stress response induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with a placebo or metyrapone, a cortisol synthesis inhibitor medication, on four different occasions.

Eligibility Criteria

This trial is for individuals interested in exploring how psilocybin, the active ingredient in 'magic mushrooms,' affects stress. Participants will be given psilocybin with either a placebo or metyrapone on four occasions. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 22 and 65 years old.

I've had no severe reactions to psychedelics before.

Exclusion Criteria

A close family member has schizophrenia, bipolar I, or II.

I have had a mild brain injury in the past 6 months or a more severe one at some point.

Participant Groups

The study tests the effects of 25 mg of psilocybin and 1 mg of psilocybin against a placebo and alongside metyrapone, which inhibits cortisol production. The goal is to understand how these treatments influence acute stress responses.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: High-dose psilocybin + metyraponeExperimental Treatment2 Interventions

750mg metyrapone + 25 mg psilocybin (+15 min) + 750mg metyrapone (+180 min)

Group II: High-dose psilocybin + placeboActive Control2 Interventions

placebo + 25 mg psilocybin (+15 min) + placebo (+180 min)

Group III: Low-dose psilocybin + metyraponeActive Control2 Interventions

750mg metyrapone + 1 mg psilocybin (+15 min) + 750mg metyrapone (+180 min)

Group IV: Low-dose psilocybin + placeboPlacebo Group2 Interventions

placebo + 1 mg psilocybin (+15 min) + placebo (+180 min)