Perception DisturbancePhase 1NCT04424225
Visual Surround Suppression and Perceptual Expectation Under Psilocybin
A Phase 1 study testing Psilocybin and Niacin in people with Perception Disturbance and Visual Suppression, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Perception Disturbance, Visual Suppression, Psychedelic Experiences
- What is being tested?
- Psilocybin and Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 1 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 48Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the detailed description
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.
- Being tested
- Psilocybin, Niacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
NiacinDrug
Also called Vitamin B3
100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin First | Experimental | Participants in this arm will receive psilocybin first, then niacin Receives: Drug: Psilocybin; Drug: Niacin |
| Niacin First | Experimental | Participants in this arm will receive niacin first, then psilocybin Receives: Drug: Psilocybin; Drug: Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
.
Measured: 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.
.
Measured: 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).
Measured: 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).
Measured: 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).
.
Measured: 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).
.
Measured: 3 hours after dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start30 Aug 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: Could not secure additional funding to continue the study. Pilot phase of study completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perception DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Heffter Research Institute
- Responsible party
- Sponsor
- Investigators
- Jessica Nielson, PhD, Principal investigator, University of MinnesotaLink Swanson, PhD(c), Study director, University of MinnesotaSophie Jungers, BS, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424225
- Sponsor's protocol ID
- PSYCH-2019-28235
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2020
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39499526Cotten 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.
PubMed 36881769
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Surround Suppression and Perceptual Expectation Under Psilocybin
- ClinicalTrials.gov ID
- NCT04424225
- Acronym / sponsor ID
- PSYCH-2019-28235
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not secure additional funding to continue the study. Pilot phase of study completed.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Heffter Research Institute
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin First | Experimental | Drug: Psilocybin, Drug: NiacinParticipants in this arm will receive psilocybin first, then niacin |
| Niacin First | Experimental | Drug: Psilocybin, Drug: NiacinParticipants in this arm will receive niacin first, then psilocybin |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (48 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) | Drug | Niacin First, Psilocybin First |
| NiacinAlso: Vitamin B3100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2) | Drug | Niacin First, Psilocybin First |
Primary outcome
Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 1
Time frame: 3 hours after 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. .
Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 2
Time frame: 3 hours after 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. .
Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 1
Time frame: 3 hours after 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).
Psychophysical Descrimination Threshold - Orthogonal Surround Suppression (OS) Dose 2
Time frame: 3 hours after 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).
Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 1
Time frame: 3 hours after 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). .
Psychophysical Descrimination Threshold - Parallel Surround Suppression (PS) Dose 2
Time frame: 3 hours after 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). .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39499526Swanson 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.
- Derived from this study: PubMed 36881769Cotten 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.
- Individual participant dataSharing planned: Yes. 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
Related trials for Perception Disturbance
Not yet recruitingObservational study
Validity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale
Complex Regional Pain Syndrome (CRPS)
Not yet recruiting
Graded Motor Imagery Effects on Body Perception Disturbance in Complex Regional Pain Syndrome : a Randomised Controlled Trial
Complex Regional Pain Syndromes
Not yet recruiting
Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients
Sleep Disturbance
Recruiting
The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
Autism, Sleep Disturbance
RecruitingObservational study
Relationships Between Nomophobia Levels and Perceived Stress, Body Image and Food Addiction Among University Students
Nomofobia, Body Image Disturbance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Nielson, PhD principal investigator
University of Minnesota
Link Swanson, PhD(c) study director
University of Minnesota
Sophie Jungers, BS study director
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin and Niacin in people with Perception Disturbance and Visual Suppression, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysical Descrimination Threshold - No Surround Suppression (NS) Dose 1 (time frame: 3 hours after dose 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.