Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Primary Purpose
Perception Disturbance, Visual Suppression, Psychedelic Experiences
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Niacin
Sponsored by
About this trial
This is an interventional basic science trial for Perception Disturbance
Eligibility Criteria
Inclusion Criteria:
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED), and be able to read and write in English
- General health status: Participants should be in good physical (BMI between 20.0 and 28.0 kg/m2) and psychiatric health.
- Experience taking psilocybin (at the PI's discretion).
- Participants must also have a person that can reliably transport them to and from the CRU for dosing session days.
- Geographic location: 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, except for 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.
- Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.
- Agrees to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
Exclusion Criteria:
- Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except 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, nicotine, and hallucinogens)
- 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.
- 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 medication or 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 or other hormone therapy
- A strong bias either for or against psychedelic substances, or if their responses about psychedelic use indicate that they abuse them from frequent use (more than once per month, with the exception of microdosing).
- 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, or tattoos that were done less than 4 weeks from the first scheduled MRI.
- 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 during in-person study visits that require them.
- Unwilling to get tested for COVID-19 and share results with study personnel prior to all in-person visits.
- Are unvaccinated against COVID-19, are not current with their COVID-19 vaccine booster, or are unwilling to share their proof of COVID-19 vaccination with the study team.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Psilocybin First
Niacin First
Arm Description
Participants in this arm will receive psilocybin first, then niacin
Participants in this arm will receive niacin first, then psilocybin
Outcomes
Primary Outcome Measures
Psychophysical Discrimination Threshold
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
Difference in Event Related Potential Amplitude
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Full Information
NCT ID
NCT04424225
First Posted
June 5, 2020
Last Updated
February 10, 2023
Sponsor
University of Minnesota
Collaborators
Heffter Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04424225
Brief Title
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Official Title
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Heffter Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perception Disturbance, Visual Suppression, Psychedelic Experiences
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin First
Arm Type
Experimental
Arm Description
Participants in this arm will receive psilocybin first, then niacin
Arm Title
Niacin First
Arm Type
Experimental
Arm Description
Participants in this arm will receive niacin first, then psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
Intervention Type
Drug
Intervention Name(s)
Niacin
Other Intervention Name(s)
Vitamin B3
Intervention Description
100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
Primary Outcome Measure Information:
Title
Psychophysical Discrimination Threshold
Description
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.
Time Frame
3-5 hours
Secondary Outcome Measure Information:
Title
Difference in Event Related Potential Amplitude
Description
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).
Time Frame
3-5 hours
Title
Change in resting state brain activity
Description
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.
Time Frame
Approximately 4 weeks
Title
Change of white matter structural connectivity
Description
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.
Time Frame
Approximately 4 weeks
Title
Positive and Negative Affect Schedule (PANAS) Positive Scale
Description
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.
Time Frame
approximately 4 weeks
Title
Positive and Negative Affect Schedule (PANAS) Negative Scale
Description
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.
Time Frame
approximately 4 weeks
Title
Revised Mystical Experience Questionnaire (RMEQ-30)
Description
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.
Time Frame
approximately 4 weeks
Title
Ego-Dissolution Inventory (EDI)
Description
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.
Time Frame
approximately 4 weeks
Title
5 Dimensions of Altered States of Consciousness (5D-ASC)
Description
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).
Time Frame
approximately 4 weeks
Title
Change in Serum Brain-Derived Neurotrophic Factor (BDNF)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum C-Reactive Protein (CRP)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Transforming Growth Factor Beta-1 (TGFb-1)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Glial Fibrillary Acidic Protein (GFAP)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Tumor Necrosis Factor Alpha (TNFa)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Interleukin-1beta (IL-1b)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Interleukin-6 (IL-6)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Interleukin-10 (IL-10)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Interferon Gamma (IFNy)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Tumor Necrosis Factor Receptor 1 (TNF-R1)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Tumor Necrosis Factor Receptor 2 (TNF-R2)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum S100 Calcium-Binding Protein B (S100B)
Description
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.
Time Frame
approximately 4 weeks
Title
Change in Serum Ubiquitin C-Terminal Hydrolase L1 (UCHL-1)
Description
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.
Time Frame
approximately 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have given written informed consent
Have at least a high-school level of education or equivalent (e.g. GED), and be able to read and write in English
General health status: Participants should be in good physical (BMI between 20.0 and 28.0 kg/m2) and psychiatric health.
Experience taking psilocybin (at the PI's discretion).
Participants must also have a person that can reliably transport them to and from the CRU for dosing session days.
Geographic location: 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, except for 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.
Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.
Agrees to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
Exclusion Criteria:
Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except 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, nicotine, and hallucinogens)
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.
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 medication or 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 or other hormone therapy
A strong bias either for or against psychedelic substances, or if their responses about psychedelic use indicate that they abuse them from frequent use (more than once per month, with the exception of microdosing).
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, or tattoos that were done less than 4 weeks from the first scheduled MRI.
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 during in-person study visits that require them.
Unwilling to get tested for COVID-19 and share results with study personnel prior to all in-person visits.
Are unvaccinated against COVID-19, are not current with their COVID-19 vaccine booster, or are unwilling to share their proof of COVID-19 vaccination with the study team.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Nielson, PhD
Phone
(612) 624-9469
Email
jnielson@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Nielson, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Link Swanson, PhD(c)
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sophie Jungers, BS
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Nielson, PhD
Phone
612-626-5168
Email
psilo001@umn.edu
First Name & Middle Initial & Last Name & Degree
Jessica Nielson, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
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