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Visual Surround Suppression and Perceptual Expectation Under Psilocybin

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ClinicalTrials.gov Identifier: NCT04424225
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The prospective 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.

Condition or disease Intervention/treatment Phase
Perception Disturbance Visual Suppression Psychedelic Experiences Drug: Psilocybin Drug: Niacin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin First
Participants in this arm will receive psilocybin first, then niacin
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

Experimental: Niacin First
Participants in this arm will receive niacin first, then psilocybin
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Participants must be willing to wear a face mask at all times during in-person study visits, including dosing sessions, to ensure COVID-19 protection
  • Participants must be willing to get a COVID-19 test and share results with the study team prior to all in-person visits

Exclusion Criteria:

  • Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder, personality disorder, major depressive disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, dysthymic disorder
  • Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)
  • Those with a first or second-degree relative with a current or past history of meeting DSM-5 criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder, because they might have an underlying genetic susceptibility for psychosis
  • Presence of symptoms of the following DSM-5 disorders within the past 6 months (as assessed by the MINI-7):

    • Major Depressive Episode
    • Suicidality
    • Manic and Hypomanic Episodes
    • Panic disorder
    • Agoraphobia
    • Social Anxiety Disorder
    • Obsessive-Compulsive Disorder
    • Posttraumatic Stress Disorder
    • Alcohol Use Disorder
    • Substance Use Disorder (Non-Alcoholic)
    • Psychotic Disorders and Mood Disorders with Psychotic Features
    • Anorexia Nervosa
    • Bulimia Nervosa
    • Binge Eating Disorder
    • Generalized Anxiety Disorder
    • Antisocial Personality Disorder
    • Mood Disorders:
    • Major Depressive Disorder (MDD)
    • MDD with Psychotic Features
    • Bipolar I
    • Bipolar II
    • Other Specified Bipolar and Related Disorder
  • Presence of abuse or dependence of drugs measured by the MINI-7 in the past 12 months:

    • Lithium, Sodium Valproate (Depakote), Lamotrigine (Lamictal) - Manic/Bipolar disorders
    • Stimulants: amphetamines, "speed", crystal meth, "crank", Dexedrine, Ritalin, diet pills
    • Cocaine: snorting, IV, freebase, crack, "speedball"
    • Opiates: heroin, morphine, Dilaudid, opium, Demerol, methadone, Darvon, codeine, Percodan, Vicodin, OxyContin
    • Hallucinogens: LSD ("acid"), mescaline, peyote, psilocybin, STP, "mushrooms", "ecstasy", MDA, MDMA
    • Dissociative Drugs: PCP (Phencyclidine, "Angel Dust", "Peace Pill", "Hog"), or ketamine ("Special K")
    • Inhalants: "glue", ethyl chloride, "rush", nitrous oxide ("laughing gas"), amyl or butyl nitrate ("poppers")
    • Cannabis: marijuana, hashish ("hash"), THC, "pot", "grass", "weed", "reefer"
    • Sedatives, Hypnotics or Anxiolytics: Quaalude, Seconal ("reds"), Valium, Xanax, Librium, Ativan, Dalmane, Halcion, barbiturates, Miltown, GHB, Roofinol, "Roofies"
    • Miscellaneous: steroids, nonprescription sleep or diet pills. Cough Medicine?
  • History of substance-induced psychosis
  • 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
  • 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)
  • MRI EXCLUSION: we will also exclude anyone 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 CMRR 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 will also be excluded
  • Uncontrolled hypertension, with an average blood pressure reading across 4 measurements over 2 separate days greater than 140/90mmHg
  • Unwilling to wear a face mask at all times during in-person study visits
  • Unwilling to get tested for COVID-19 and share results with study personnel prior to all in-person visits

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): NCT04424225


Contacts
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Contact: Jessica Nielson, PhD (612) 624-9469 jnielson@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jessica Nielson, PhD    612-626-5168    psilo001@umn.edu   
Principal Investigator: Jessica Nielson, PhD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Jessica Nielson, PhD University of Minnesota
Study Director: Link Swanson, PhD(c) University of Minnesota
Study Director: Sophie Jungers, BS University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04424225    
Other Study ID Numbers: PSYCH-2019-28235
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: For data releases, requests for sharing will be made to the PI, Jessica Nielson or the student investigator, Link Swanson, and/or co-investigators Michael-Paul Schallmo, Kathryn Cullen, or Ranji Varghese and granted on an individual basis

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Niacin
Psilocybin
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Hallucinogens
Psychotropic Drugs