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Trial record 13 of 14 for:    psilocybin | Psilocybin | First posted from 07/30/2018 to 03/21/2020

Characterization of Altered Waking States of Consciousness in Healthy Humans

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ClinicalTrials.gov Identifier: NCT03853577
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Altered waking states of consciousness and its underlying functional organization have gained increasing interest in recent years, i.e. in identifying the neural basis of consciousness. To overcome fundamental shortcomings of current methods to objectively assess the level of consciousness, the investigators propose here to apply a novel and empirically validated measure called 'perturbational complexity index' (PCI) based on the integrated information theory (IIT). This involves a combination of transcranial magnetic stimulation (TMS) and highdensity electroencephalography (hd-EEG) to measure electrocortical responses as distributed cerebral interactions ('integration') and spatiotemporal pattern ('information'). Given the finding of subjectively expanded consciousness as induced here by psilocybin, the investigators hypothesize that the PCI may be higher in such states. This will be the first TMS/hd-EEG study to investigate quantitatively the level of consciousness in a pharmacologically altered waking state of consciousness.

Condition or disease Intervention/treatment Phase
Altered Waking States of Consciousness in Healthy Humans Other: TMS/EEG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Characterization of Altered Waking States of Consciousness in Healthy Humans
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Psilocybin Other: TMS/EEG
navigated TMS/high-density(hd)-EEG to directly stimulate defined cortical areas and investigate quantitatively the level of consciousness in psilocybin-induced altered brain states

Placebo Comparator: Placebo Other: TMS/EEG
navigated TMS/high-density(hd)-EEG to directly stimulate defined cortical areas and investigate quantitatively the level of consciousness in psilocybin-induced altered brain states




Primary Outcome Measures :
  1. Assessment of change of the 'perturbational complexity index' (PCI) in psilocybin compared to placebo condition in healthy humans as indexed by TMS/EEG respones [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of navigated TMS/EEG over the premotor cortex (Brodmann-Area BA06), the midline sensorimotor cortex (BA04) and the superior occipital gyrus/cuneus (BA19)


Secondary Outcome Measures :
  1. Assessment of change of the learning rate in a probabilistic learning task in psilocybin compared to placebo condition [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of a probabilistic learning task to examine the computational processes behind the interaction between reward learning and subconscious/conscious emotional processing

  2. Assessment of change of the effect of psilocybin compared to placebo condition on all frequency bands of resting state EEG [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Resting state EEG will be collected before and after TMS/EEG sessions. This data will be used to calculate the 'current source density' (CSD) and the 'laged phase synchronization', serving as biomarkers for insightfulness and spiritual experience. More specifically, eight frequency will be investigated: delta (1.5-4 Hz), theta (4-8 Hz), alpha1 (8-10.5 Hz), alpha2 (10.5-13 Hz), beta1 (13-20 Hz), beta2 (20-30 Hz), gamma1 (30-45 Hz), gamma2 (55- 100 Hz)

  3. Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (1) [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of the 'Hood's Mysticism-Scale' (MS) before and after TMS/EEG sessions. The revised and validated Hood's Mysticism-Scale describes a measure of reported mystical experience. Items on this scale are positively and negatively expressed, and they comprise two major factors, a general mystical experience factor and a religious interpretation factor. The scale ranges from +4 (very correct) to -4 (very wrong)

  4. Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (2) [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of the '5-Dimensional Altered States of Consciousness Rating Scale' (5D-ASC) before and after TMS/EEG sessions. It is a retrospectively assessed questionnaire to measure subjective experiences of altered states of consciousness. It contains 94 items which are formulated as a visual analog scale. It contains five primary dimensions a global dimension of altered states of onsciousness: Oceanic boundlessness (OSE), Dread of Ego dissolution (AIA), Visionary restructuralization (VUS), Auditive alteration (AVE) and Vigilance reduction (VIR). The first-mentioned three dimensions correlate with each other and form a global dimension (G-ABZ). The visual analog scale (VAS) ranges from 0 (not perceived) to 10 (very strongly perceived)

  5. Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (3) [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of the 'Positive and Negative Affect Schedule' (PANAS) before and after TMS/EEG sessions. This is a questionnaire with 20 items about positive and negative affect. They reflect dispositional dimensions. A high score on negative affect is coupled with subjective distress and unpleasurable engagement. Positive affect represents the extent to which an individual experiences pleasurable engagement with the environment. The scale ranges from +2 (very strong) to -2 (very weak)

  6. Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (4) [ Time Frame: First investigational visit at week 1, second investigational visit at week 3 ]
    Application of the the 'Interoception Rating Scale' (IRS) before and after TMS/EEG sessions. The Interoception Rating Scale is a measure of numerous facets of interoception (e.g. intensity of heartbeat or breathing) with 14 items. Dial ratings on the VAS can range from 0 (none) to 100 (most intense)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female volunteers aged 18-40 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853577


Contacts
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Contact: Franz X. Vollenweider, Prof, MD +41 44 384 24 04 vollen@bli.uzh.ch
Contact: Andres C. Ort, MD +41 44 384 27 50 ort@bli.uzh.ch

Locations
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Switzerland
Psychiatrische Universitätsklinik Zürich Recruiting
Zürich, Switzerland, 8032
Contact: Franz X. Vollenweider, Prof, MD    +41 44 384 24 04    vollen@bli.uzh.ch   
Contact: Andres C. Ort, MD    +41 44 384 27 50    ort@bli.uzh.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Franz X. Vollenweider, Prof, MD Psychiatric Hospital, University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03853577    
Other Study ID Numbers: PSICON-132
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs