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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Active Comparator |
| |
| Placebo | Placebo Comparator | Psilocybin vs Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin (drug) | Drug | One arm will receive psilocybin 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 AG (pmol/mL) , 2 OG (pmol/mL) , AEA (pmol/mL) , OEA (pmol/mL) , PEA (pmol/mL) | Plasmatic Endocannabinoids | Baseline to 7 days post-dose |
| Trp (μg/mL) , Kyn (ng/mL) , Kyn/Trp*1000 , 5 HT (ng/mL) | Tryptophan Pathways | Baseline to 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DNA methylation | DNA methylation and histone modification) analysis of genes involved in spirituality and resilience | Baseline and 1 week after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryam Oraei, MD | Contact | +1-514-3984650 | maryam.oraei@mcgill.ca |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Placebo | Drug | One group will receive a placebo pill |
|
| 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. | 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. | 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. | Before the administration of psilocybin or placebo and during the effect of the drug (about 6 hours). |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |