The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorGabriella Gobbi
About this trial
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.
Eligibility criteria
Qualifiers
Male or Female adults ages 21-65 at the time of screening.
Females of childbearing potential must have a negative pregnancy test at all designated visits.
Have a self-reported interest in psychedelic drugs and altered states of consciousness.
Never have used a classic, serotonergic psychedelic (such as psilocybin, psilocybin, LSD, or ayahuasca) or a dissociative anesthetic such as ketamine or PCP), or maximum one experience 5 years before the study starting without untoward effects.
Disqualifiers
Any psychiatric, cardiovascular, neurological, or other disorders that may be aggravated by participation in the study, or complicate interpretation of the study's results.
Any substance use disorder.
For women, a positive pregnancy test, or not using a reliable method of birth control.
Personal or family history of severe psychiatric disorders (schizophrenia, bipolar disorder, addiction, ASD) and/or psychosis in the first and second degree.
Trial design
Treatments tested in this trial
- Psilocybin (drug)
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Gabriella Gobbi
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
Source ClinicalTrials.gov