The Effects of Psilocybin in Healthy Volunteers:... — Clinical Trial Details

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

This Phase I, randomized, triple-blind, parallel-group trial (n=50) will study the effects of a single 25 mg oral dose of psilocybin versus placebo in healthy adult volunteers aged 21–65, with the primary aim of characterising biological, psychological and high-density EEG (hd-EEG) biomarkers and related safety/tolerability following one-time administration. Participants will be randomised to receive either psilocybin 25 mg (one tablet by mouth) or a matching inactive placebo; the psilocybin is supplied by Filament Health (Burnaby, British Columbia). Key eligibility includes ages 21–65, BMI 18–34 kg/m2, no current or past substance use disorder, limited prior psychedelic exposure (never or at most one prior classic serotonergic psychedelic experience more than 5 years earlier), and contraception/pregnancy requirements for women of childbearing potential. Primary biochemical outcomes measured from baseline to 7 days post-dose include 2 AG (pmol/mL), 2 OG (pmol/mL), AEA (pmol/mL), OEA (pmol/mL), PEA (pmol/mL), Trp (μg/mL), Kyn (ng/mL), Kyn/Trp*1000 and 5 HT (ng/mL); psychological and hd-EEG measures will also be assessed. The study is scheduled to start 2026-09-01 with estimated completion 2029-09-01.

Detailed Description

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.

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

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.
Participants must be free of current or past substance use dependence or disorders, as determined by a semi-structured clinical interview for DSM-5 diagnoses (SCID-DSM-5).
Have a Body Max Index (BMI) 18-34 kg/m2 and an abdomen circumference ≤ 90 for women and 97 for men.
In the investigator's opinion, participants are reliable and willing and able to comply with the protocol requirements and procedures.
In addition to meeting the inclusion criteria outlined, it is important to develop a positive rapport between all individuals both participating in and coordinating the study.

Exclusion Criteria

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.
During the interview family history is asked in detail. Example: Did your parents or grandparents received a diagnosis of schizophrenia, bipolar disorder, depression.... Did somebody die by suicide? ...Did somebody was hospitalized in a psychiatric hospital? Did somebody in the family was judged "strange"? Different? Even if 40 years ago the diagnosis of depression or bipolar disorder was less precise, do you have the impression that somebody was sick?
A resting blood pressure \> 140 systolic and 90 diastolic (mmHg).
Cardiovascular diseases including valvulopathy.
Current tricyclic antidepressant, lithium, SSRIs, first- and second-generation ketamine antipsychotics, or MAOI prescription regimen.
Current dietary supplementation of 5-hydroxytryptophan and St. John's Wort.
Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. CLRC \< 30 ml/min etc.).
History of serious suicide attempts requiring hospitalization.
Significant history of mania (determined by study psychiatrist and medical records).
Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder.
Blood or needle phobia.
Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
Use of contraindicated medication.

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

Detailed Description

Study Arms & Interventions

Psilocybin

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details