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

ConditionsHealthy Participants Placebo - Control Psilocybin

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Psilocybin (drug)
Drug
One arm will receive psilocybin 25 mg
Placebo
Drug
One group will receive a placebo pill

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: PsilocybinActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

2 AG (pmol/mL) , 2 OG (pmol/mL) , AEA (pmol/mL) , OEA (pmol/mL) , PEA (pmol/mL)

Plasmatic Endocannabinoids

Time frame

Baseline to 7 days post-dose

Trp (μg/mL) , Kyn (ng/mL) , Kyn/Trp*1000 , 5 HT (ng/mL)

Tryptophan Pathways

Time frame

Baseline to 7 days post-dose

Secondary outcomes

Interpersonal Reactivity Index (IRI)

Interpersonal Reactivity Index (IRI, 28 items): A multidimensional assessment of empathy. There are 4 subitems measuring Perspective Taking, the tendency to spontaneously adopt the psychological point of view of others; Fantasy, one's tendency to transpose themselves imaginatively into the feelings and actions of fictitious characters; Empathic Concern, feelings of sympathy and concern for unfortunate others; and Personal Distress, feelings of personal anxiety and unease in tense interpersonal settings.

Time frame

Baseline to 7 days post-dose

Multifaceted Empathy Test (MET) Scores

The Multifaceted Empathy Test (MET) is used to measure empathy competence. It consists of a series of photorealistic images showing people in emotionally charged situations. The test yields two primary sub-scores: 1) Cognitive Empathy: Participants infer the mental state of the person in the image; 2) Emotional Empathy: Participants rate their own emotional reaction to the image (e.g., "How much do you feel for this person?"). Responses are typically recorded on a Likert scale (e.g., 1-9), where 1 represents "not at all" and 9 represents "very strong." Scores are summed for each component, with higher scores indicating higher levels of empathy.

Time frame

Baseline to 7 days post-dose

Profile of Mood States (POMS)

POMS is a 65 item scales which assesses transient mood states in individuals 18 and older. The scale has been widely used within clinical psychiatric and psychotherapeutic environments for the purpose of assessing individuals' mood-related treatment responses. There are 6 subscales, including Tension-Anxiety, Depression, Anger-Hostility, Fatigue, Confusion-Bewilderment, and Vigour-Activity. The scale has been validated widely and possesses test-retest reliability.

Time frame

From Baseline to 1 week after treatment

High Density Electroecephalogram (hd-EEG)

High-density electroencephalography (hd-EEG) is a non-invasive method used to record electrical brain activity from multiple electrodes placed on the scalp. This technique provides detailed information about brain function and neural activity. In this study, hd-EEG will be used to assess changes in brain activity following study drug administration. The procedure is painless and involves wearing an electrode cap for approximately 20-40 minutes.

Time frame

Before the administration of psilocybin or placebo and during the effect of the drug (about 6 hours).

Other outcomes

DNA methylation

DNA methylation and histone modification) analysis of genes involved in spirituality and resilience

Time frame

Baseline and 1 week after treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gabriella Gobbi

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: