Clinical TrialHealthy VolunteersPsilocybinPlaceboCompleted

Characterization of Altered Waking States of Consciousness in Healthy Humans

Randomised, double-blind, placebo-controlled crossover study (n=25) testing a single 20 mg oral psilocybin dose versus placebo in healthy volunteers, measuring perturbational complexity index (PCI) with TMS/hd-EEG.

Target Enrollment
25 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This single-centre, randomized, double-blind crossover study in healthy volunteers applies a single 20 mg oral psilocybin dose versus placebo to investigate altered waking states of consciousness using navigated TMS coupled with high-density EEG (TMS/hd-EEG).

Primary outcome is the perturbational complexity index (PCI) measured at the acute phase (approximately 80 minutes after substance intake) across targeted cortical areas (premotor BA06, midline sensorimotor BA04, superior occipital gyrus/cuneus BA19).

Secondary analyses include resting-state EEG measures (current source density, lagged phase synchronization) and psychometric assessments (5-Dimensional ASC, Hood's Mysticism Scale, PANAS), plus a probabilistic learning task to probe emotional learning rates.

Design: screening visit, two investigational visits in counterbalanced order (psilocybin and placebo), and a 12-week follow-up; approved by KEK Zurich and conducted at Psychiatrische Universitätsklinik Zürich.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single 20 mg psilocybin session (crossover) with concurrent navigated TMS/hd-EEG measurements.

Interventions

  • Psilocybin20 mg
    via Oral• single dose

    Single 20 mg oral psilocybin per investigational visit.

  • Compound
    via Other• single dose

    Navigated TMS/high-density EEG (TMS/hd-EEG) applied to target cortical areas during acute phase.

Placebo

inactive

Placebo (mannitol) session with same TMS/hd-EEG protocol, crossover design.

Interventions

  • Placebo
    via Oral• single dose

    Mannitol placebo matching psilocybin session.

  • Compound
    via Other• single dose

    Navigated TMS/high-density EEG (TMS/hd-EEG) applied as in active arm.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Healthy male or female volunteers aged 18-40 years.
  • Participants must be medically and psychiatrically healthy and able to give informed consent.

Exclusion Criteria

  • Personal or family history of major psychiatric disease (e.g. major depression, bipolar disorder, psychotic disorder) as defined in DSM-V.
  • Any major medical condition (e.g. neurologic, cardiovascular, metabolic disease) or family history of seizure disorder.
  • Current psychopharmacological treatment or use of medication.
  • Pregnant or breastfeeding women.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment25 participants
  • Timeline
    Start: 2020-07-08
    End: 2021-04-25
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

Psychiatrische Universitätsklinik Zürich — Zurich, Switzerland

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