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The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.

NCT07433452 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-25

No results posted yet for this study

Summary

In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia).

After psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor.

This study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research.

The goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.

Conditions

  • Healthy Participants
  • Placebo - Control
  • Psilocybin

Interventions

DRUG

Psilocybin (drug)

One arm will receive psilocybin 25 mg

DRUG

Placebo

One group will receive a placebo pill

Sponsors & Collaborators

  • Gabriella Gobbi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2029-09-01

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433452 on ClinicalTrials.gov