Clinical TrialNeuroimaging & Brain MeasuresPsilocybinPlaceboPlaceboPsilocybinNot yet recruiting

Effects of Psilocybin on Shared Experience

Randomised, crossover study (n=30) comparing 15 mg oral psilocybin with placebo in healthy volunteers to assess effects on brain synchrony and cognition during film viewing.

Target Enrollment
30 participants
Study Type
Phase NA interventional
Design
Randomized

Detailed Description

This randomized, two-session crossover study in healthy volunteers tests whether 15 mg oral psilocybin alters inter-subject brain synchrony measured with fMRI while participants watch film clips, perform mental imagery tasks, and listen to music.

Each participant completes one psilocybin and one placebo scanning session at least two weeks apart; cognitive testing, questionnaires on plot comprehension and subjective experience, visual illusion tasks and web-based cognitive games follow scans.

The study aims to inform neuroimaging methods for detecting awareness in disorders of consciousness by determining whether psilocybin modulates brain synchrony during shared stimulus exposure.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin First

experimental

Receive 15 mg oral psilocybin in first scanning session, placebo in second (≥2 week washout).

Interventions

  • Psilocybin15 mg
    via Oral• single dose• 1 doses total

    15 mg oral psilocybin given prior to fMRI session.

  • Placebo
    via Oral• single dose• 1 doses total

    Oral placebo given in alternate session.

Placebo First

experimental

Receive placebo in first scanning session, 15 mg oral psilocybin in second (≥2 week washout).

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Oral placebo given in first session.

  • Psilocybin15 mg
    via Oral• single dose• 1 doses total

    15 mg oral psilocybin given in second session.

Participants

Ages
19 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participants must:
  • Have access to an internet connection
  • Be in good general health
  • Be 19 years of age, or older
  • Be willing to follow the study protocol

Exclusion Criteria

  • Exclusion Criteria:
  • Participants will be excluded if they:
  • Are unable to read English
  • Have high blood pressure
  • Are pregnant (determined by a urine pregnancy test at in-person screening)
  • Are not using effective methods of contraception with their partner(s)
  • Are taking chronic tricyclic antidepressants and/or lithium
  • Are taking acute administration of serotonin reuptake inhibitors
  • Are currently using the antipsychotic medication haloperidol
  • Are currently using monoamine oxidase inhibitors
  • Have any current or past history meeting DSM‑V criteria for schizophrenia, bipolar I, bipolar II, or psychotic symptoms
  • Have any first or second-degree relatives with a history of the above disorders/symptoms
  • Have any other diagnosed and/or extreme psychiatric disorders (e.g., anxiety, depression, PTSD, addiction, OCD)
  • Have any history of suicidal behaviour or current/recent suicidal ideation (determined by the Columbia-Suicide Severity Rating Scale [C-SSRS] at in-person screening)

Study Details

Locations

Canada

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