Not provided
Not provided
Not provided
Not provided
Not provided
Could not secure additional funding to continue the study. Pilot phase of study completed.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heffter Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
The prospective pilot 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 proposed pilot 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin First | Experimental | Participants in this arm will receive psilocybin first, then niacin |
|
| Niacin First | Experimental | Participants in this arm will receive niacin first, then psilocybin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | 25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 1 | No surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. . | 3 hours after dose 1 |
| Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 2 | No surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. . | 3 hours after dose 2 |
| Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 1 | Orthogonal surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Orthogonal surround suppression condition (OS). | 3 hours after dose 1 |
| Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 2 | Orthogonal surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Orthogonal surround suppression condition (OS). |
Not provided
Not provided
Inclusion Criteria:
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):
Presence of abuse or dependence of drugs measured by the MINI-7 in the past 12 months:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jessica Nielson, PhD | University of Minnesota | Principal Investigator |
| Link Swanson, PhD(c) | University of Minnesota | Study Director |
| Sophie Jungers, BS | University of Minnesota | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499526 | Result | Swanson LR, Jungers S, Varghese R, Cullen KR, Evans MD, Nielson JL, Schallmo MP. Enhanced visual contrast suppression during peak psilocybin effects: Psychophysical results from a pilot randomized controlled trial. J Vis. 2024 Nov 4;24(12):5. doi: 10.1167/jov.24.12.5. | |
| 36881769 | Derived | Cotten SW, Strathmann FG, Barrett FS, Labay L, Mullally J, Sherwood AM, Wiegand F. Psychedelics for Medicinal Use: How Will This Alter the Collective Laboratory Consciousness? Clin Chem. 2023 Apr 3;69(4):319-326. doi: 10.1093/clinchem/hvad016. No abstract available. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Psilocybin First, Niacin Second | Participants in this arm will receive psilocybin first, then niacin Psilocybin: 25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) Niacin: 100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
| FG001 | Niacin First, Psilocybin Second | Participants in this arm will receive niacin first, then psilocybin Psilocybin: 25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) Niacin: 100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psilocybin First, Niacin Second | Participants in this arm will receive psilocybin first, then niacin Psilocybin: 25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) Niacin: 100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
| BG001 | Niacin First, Psilocybin Second |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 1 | No surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. . | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 1 |
|
Week 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psilocybin | Received Psilocybin | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BackPain | General disorders | Non-systematic Assessment |
The study was terminated early due to lack of funding. Data from primary outcome for psychophysics and secondary analysis for visual event related potentials (vERP) are for the first 6 participants, as part of Dr. Link Swansons dissertation. Raw neuroimaging data will be deposited into OpenNeuro for ongoing data analysis and data sharing with the broader research community.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Nielson | University of Minnesota | 714-904-7939 | jnielson@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2023 | Apr 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2023 | Apr 2, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D009525 | Niacin |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Niacin | Drug | 100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
|
|
| 3 hours after dose 2 |
| Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 1 | Parallel surround suppresion condition for visual psychophysics tasks consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Parallel surround suppression condition (PS). . | 3 hours after dose 1 |
| Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 2 | Parallel surround suppresion condition for visual psychophysics tasks consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Parallel surround suppression condition (PS). . | 3 hours after dose 2 |
Participants in this arm will receive niacin first, then psilocybin Psilocybin: 25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) Niacin: 100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 2 | No surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. . | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 2 |
|
|
|
| Primary | Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 1 | Orthogonal surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Orthogonal surround suppression condition (OS). | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 1 |
|
|
|
| Primary | Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 2 | Orthogonal surround suppression condition for visual psychophysics tasks, consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Orthogonal surround suppression condition (OS). | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 2 |
|
|
|
| Primary | Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 1 | Parallel surround suppresion condition for visual psychophysics tasks consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Parallel surround suppression condition (PS). . | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 1 |
|
|
|
| Primary | Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 2 | Parallel surround suppresion condition for visual psychophysics tasks consisting of perceptual judgments (e.g., subject reported which of two visual stimuli presented appeared 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. Parallel surround suppression condition (PS). . | Posted | Mean | Standard Deviation | percent contrast | 3 hours after dose 2 |
|
|
|
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | Niacin | Received Niacin | 0 | 8 | 0 | 8 | 5 | 8 |
| Headache | General disorders | Non-systematic Assessment |
|
| sleep disturbance | General disorders | Non-systematic Assessment |
|
| stomach pain | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Emotional | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |