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Visual Surround Suppression and Perceptual Expectation Under Psilocybin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424225
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date August 27, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
Psychophysical Discrimination Threshold [ Time Frame: 3-5 hours ]
Visual psychophysics tasks will consist of perceptual judgments (e.g., subject will report which of two visual stimuli presented appears to have higher contrast). Based on these responses, psychophysical discrimination thresholds are calculated using an adaptive staircase technique and reported in units of percent contrast.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • Difference in Event Related Potential Amplitude [ Time Frame: 3-5 hours ]
    Electroencephalography (EEG) will be collected during a visual surround suppression task and event related potential (ERP) amplitudes (in units of microvolts/millisecond) will be compared for visual target stimuli in different stimulus conditions (e.g., with vs. without surrounding stimuli).
  • Change in resting state brain activity [ Time Frame: Approximately 4 weeks ]
    Changes in brain connectivity, which will be measured with functional Magnetic Resonance Imaging (fMRI) while participants are at rest. Measurements will be taken at baseline, and 1 day, 3 days, and 7 days after each dosing session.
  • Change of white matter structural connectivity [ Time Frame: Approximately 4 weeks ]
    Structural networks were weighted by measures of white matter microstructure of Neurite orientation dispersion and density imaging (NODDI) (fractional anisotropy, neurite density and orientation dispersion index). Measurements will be taken at baseline, and 1 day, 3 days, and 7 days after each dosing session.
  • Positive and Negative Affect Schedule (PANAS) Positive Scale [ Time Frame: approximately 4 weeks ]
    The positive and negative affect schedule is a self-report questionnaire that consists of two 10-item scales - positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive scale score is calculated as the sum of items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores range from 10-50, with higher scores representing higher levels of positive affect.
  • Positive and Negative Affect Schedule (PANAS) Negative Scale [ Time Frame: approximately 4 weeks ]
    The positive and negative affect schedule is a self-report questionnaire that consists of two 10-item scales - positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Negative scale score is calculated as the sum of items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores range from 10-50, with higher scores representing higher negative affect.
  • Revised Mystical Experience Questionnaire (RMEQ-30) [ Time Frame: approximately 4 weeks ]
    The Revised Mystical Experience Questionnaire, a self-report of experiences associated with psilocybin use, contains 30 items rated on a scale from 0 (none; not at all) to 5 (extreme). From the report, 4 scores are produced - Mystical Experience, Positive Mood, Transcendence of Time and Space, and Ineffability.
    • The mystical experience score is calculated by summing 15 items scores and ranges from 0 to 75, with higher scores indicating a stronger mystical experience.
    • The positive mood score is calculated by summing 6 items scores and ranges from 0 to 30, with higher scores indicating greater positive mood.
    • The transcendence of time and space score is calculated by summing 6 items scores and ranges from 0 to 30, with higher scores indicating greater transcendence of space and time.
    • The ineffability score is calculated by summing 3 items scores and ranges from 0 to 15, with higher scores indicating greater feelings of ineffability.
  • Ego-Dissolution Inventory (EDI) [ Time Frame: approximately 4 weeks ]
    The ego-dissolution inventory (EDI) contains 16 items relating to altered ego-consciousness - 8 items relating to the experience of ego-dissolution and 8 items relating to the antithetical experience of ego-inflation. Items are rated using a visual analog scale that is converted to a numeric range from 0-100.
    • The ego-dissolution score is calculated as an unweighted average of the 8 items relating to the experience of ego dissolution. Scores for this subscale range from 0-100, with higher scores indicating greater ego dissolution.
    • The ego-inflation score if calculated as an unweighted average of the 8 items relating to the experience of ego inflation. Scores for this subscale range from 0-100, with higher scores indicating greater ego inflation.
  • 5 Dimensions of Altered States of Consciousness (5D-ASC) [ Time Frame: approximately 4 weeks ]
    The 5 Dimensions of Altered States of Consciousness contains 94 items and 5 sub-scales: Oceanic Boundlessness (OB, 27 items), Anxious Ego Dissolution (AED, 21 items), Auditory Alterations (AA, 15 items), Vigilance Reduction (VIR, 12 items), Visionary Restructuralization (VR, 18 items). Each item is rated using a visual analogue scale from 0-10. Scores are presented as % of scale maximum (either total for total score, or subtotal for each sub-score).
  • Change in Serum Brain-Derived Neurotrophic Factor (BDNF) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of BDNF using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of BDNF will be reported in units of pg/ml.
  • Change in Serum C-Reactive Protein (CRP) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of CRP using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of CRP will be reported in units of ng/ml.
  • Change in Serum Transforming Growth Factor Beta-1 (TGFb-1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TGFb-1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TGFb-1 will be reported in units of pg/ml.
  • Change in Serum Glial Fibrillary Acidic Protein (GFAP) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of GFAP using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of GFAP will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Alpha (TNFa) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNFa using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNFa will be reported in units of pg/ml.
  • Change in Serum Interleukin-1beta (IL-1b) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-1b using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-1b will be reported in units of pg/ml.
  • Change in Serum Interleukin-6 (IL-6) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-6 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-6 will be reported in units of pg/ml.
  • Change in Serum Interleukin-10 (IL-10) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-10 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-10 will be reported in units of pg/ml.
  • Change in Serum Interferon Gamma (IFNy) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IFNy using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IFNy will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Receptor 1 (TNF-R1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNF-R1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNF-R1 will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Receptor 2 (TNF-R2) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNF-R2 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNF-R2 will be reported in units of pg/ml.
  • Change in Serum S100 Calcium-Binding Protein B (S100B) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of S100B using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of S100B will be reported in units of pg/ml.
  • Change in Serum Ubiquitin C-Terminal Hydrolase L1 (UCHL-1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of UCHL-1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of UCHL-1 will be reported in units of pg/ml.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • Difference in Event Related Potential Amplitude [ Time Frame: 3-5 hours ]
    Electroencephalography (EEG) will be collected during a visual surround suppression task and event related potential (ERP) amplitudes (in units of microvolts/millisecond) will be compared for visual target stimuli in different stimulus conditions (e.g., with vs. without surrounding stimuli).
  • Positive and Negative Affect Schedule (PANAS) Positive Scale [ Time Frame: approximately 4 weeks ]
    The positive and negative affect schedule is a self-report questionnaire that consists of two 10-item scales - positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive scale score is calculated as the sum of items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores range from 10-50, with higher scores representing higher levels of positive affect.
  • Positive and Negative Affect Schedule (PANAS) Negative Scale [ Time Frame: approximately 4 weeks ]
    The positive and negative affect schedule is a self-report questionnaire that consists of two 10-item scales - positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Negative scale score is calculated as the sum of items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores range from 10-50, with higher scores representing higher negative affect.
  • Revised Mystical Experience Questionnaire (RMEQ-30) [ Time Frame: approximately 4 weeks ]
    The Revised Mystical Experience Questionnaire, a self-report of experiences associated with psilocybin use, contains 30 items rated on a scale from 0 (none; not at all) to 5 (extreme). From the report, 4 scores are produced - Mystical Experience, Positive Mood, Transcendence of Time and Space, and Ineffability.
    • The mystical experience score is calculated by summing 15 items scores and ranges from 0 to 75, with higher scores indicating a stronger mystical experience.
    • The positive mood score is calculated by summing 6 items scores and ranges from 0 to 30, with higher scores indicating greater positive mood.
    • The transcendence of time and space score is calculated by summing 6 items scores and ranges from 0 to 30, with higher scores indicating greater transcendence of space and time.
    • The ineffability score is calculated by summing 3 items scores and ranges from 0 to 15, with higher scores indicating greater feelings of ineffability.
  • Ego-Dissolution Inventory (EDI) [ Time Frame: approximately 4 weeks ]
    The ego-dissolution inventory (EDI) contains 16 items relating to altered ego-consciousness - 8 items relating to the experience of ego-dissolution and 8 items relating to the antithetical experience of ego-inflation. Items are rated using a visual analog scale that is converted to a numeric range from 0-100.
    • The ego-dissolution score is calculated as an unweighted average of the 8 items relating to the experience of ego dissolution. Scores for this subscale range from 0-100, with higher scores indicating greater ego dissolution.
    • The ego-inflation score if calculated as an unweighted average of the 8 items relating to the experience of ego inflation. Scores for this subscale range from 0-100, with higher scores indicating greater ego inflation.
  • 5 Dimensions of Altered States of Consciousness (5D-ASC) [ Time Frame: approximately 4 weeks ]
    The 5 Dimensions of Altered States of Consciousness contains 94 items and 5 sub-scales: Oceanic Boundlessness (OB, 27 items), Anxious Ego Dissolution (AED, 21 items), Auditory Alterations (AA, 15 items), Vigilance Reduction (VIR, 12 items), Visionary Restructuralization (VR, 18 items). Each item is rated using a visual analogue scale from 0-10. Scores are presented as % of scale maximum (either total for total score, or subtotal for each sub-score).
  • Change in Serum Brain-Derived Neurotrophic Factor (BDNF) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of BDNF using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of BDNF will be reported in units of pg/ml.
  • Change in Serum C-Reactive Protein (CRP) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of CRP using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of CRP will be reported in units of ng/ml.
  • Change in Serum Transforming Growth Factor Beta-1 (TGFb-1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TGFb-1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TGFb-1 will be reported in units of pg/ml.
  • Change in Serum Glial Fibrillary Acidic Protein (GFAP) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of GFAP using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of GFAP will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Alpha (TNFa) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNFa using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNFa will be reported in units of pg/ml.
  • Change in Serum Interleukin-1beta (IL-1b) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-1b using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-1b will be reported in units of pg/ml.
  • Change in Serum Interleukin-6 (IL-6) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-6 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-6 will be reported in units of pg/ml.
  • Change in Serum Interleukin-10 (IL-10) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IL-10 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IL-10 will be reported in units of pg/ml.
  • Change in Serum Interferon Gamma (IFNy) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of IFNy using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of IFNy will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Receptor 1 (TNF-R1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNF-R1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNF-R1 will be reported in units of pg/ml.
  • Change in Serum Tumor Necrosis Factor Receptor 2 (TNF-R2) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of TNF-R2 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of TNF-R2 will be reported in units of pg/ml.
  • Change in Serum S100 Calcium-Binding Protein B (S100B) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of S100B using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of S100B will be reported in units of pg/ml.
  • Change in Serum Ubiquitin C-Terminal Hydrolase L1 (UCHL-1) [ Time Frame: approximately 4 weeks ]
    Serum will be collected at baseline and post each treatment for the measurement of UCHL-1 using enzyme-linked immunosorbent assay (ELISA). Change in serum concentrations of UCHL-1 will be reported in units of pg/ml.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Official Title  ICMJE Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Brief Summary

Aim 1a will test the acute impact of psilocybin on the strength of the psychophysical surround suppression effect.

Aim 1b will test the acute impact of psilocybin on the strength of known surround suppression-related vERPs measured with EEG.

Detailed Description The proposed study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. The data collected in the proposed experiment will make important contributions to knowledge of how psilocybin impacts contextual processing in the brain. Moreover, this will in turn inform the neurobiology of visual surround suppression in general, providing the first investigation of links between surround suppression and serotonergic pathways in humans. Furthermore, the impact of psilocybin on surround suppression will complement recent discoveries of differences in surround suppression present in certain clinical populations. Taken together, these points suggest that this relatively simple and straightforward study could have significant payoff in its contribution to knowledge, not only of the effects of psilocybin but also of key brain processes underpinning human vision and context processing more broadly.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Perception Disturbance
Intervention  ICMJE
  • Drug: Psilocybin
    25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
  • Drug: Niacin
    100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
    Other Name: Vitamin B3
Study Arms  ICMJE
  • Experimental: Psilocybin First
    Participants in this arm will receive psilocybin first, then niacin
    Interventions:
    • Drug: Psilocybin
    • Drug: Niacin
  • Experimental: Niacin First
    Participants in this arm will receive niacin first, then psilocybin
    Interventions:
    • Drug: Psilocybin
    • Drug: Niacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2024
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Good physical health
  • BMI between 20.0 and 28.0 kg/m^2
  • No current or previously-diagnosed major mental illnesses, as determined by the Diagnostic and Statistical Manual (DSM, see exclusion criteria below)
  • Experience taking psilocybin (at the PI's discretion)
  • Must be able to read and write in English
  • Must have a person that can reliably transport them to and from the Clinical Research Unit at the University of Minnesota for dosing session days
  • Participants should be from Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including not limited to Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn

Exclusion Criteria:

  • History of psychosis, particularly any psychotic disorder
  • History of medication-induced psychosis
  • Diagnosis and/or immediate family member with a diagnosis of psychotic disorder, bipolar disorder, personality disorder, major depressive disorder, post traumatic stress disorder, or medically significant condition considered unsuitable for the current study (e.g. diabetes, epilepsy, severe cardiovascular disease, etc)
  • History of suicide attempts or mania
  • Positive pregnancy test or currently breast-feeding
  • Currently taking on a regular (e.g., daily) basis any prescription medications, with the exception of birth control
  • Current drug or alcohol dependence
  • A strong bias either for or against psychedelic substances, including claims that they love or are afraid of psychedelics, or if their responses about psychedelics indicate that they abuse them from frequent use (more than once per month)
  • Due to the fact that MRI will be conducted on the study participants, participants with head trauma, claustrophobia incompatible with scanning, cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant, prior history as a metal worker and/or certain metallic objects in the body that cannot be approved for MR scanning by the Center for Magnetic Resonance Research safety committee, history of clinically significant vertigo, seizure disorder, middle ear disorder, or double vision.
  • Significant movement disorders including tardive dyskinesia that could disrupt EEG recordings
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jessica Nielson, PhD (612) 624-9469 jnielson@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04424225
Other Study ID Numbers  ICMJE PSYCH-2019-28235
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jessica Nielson, PhD University of Minnesota
Study Director: Link Swanson, PhD(c) University of Minnesota
PRS Account University of Minnesota
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP