Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1: testing Psilocybin (Usona Institute) for Phase I
The primary aim of this phase I mechanistic pilot study is to measure the effects of psilocybin on aspects of cognition in healthy adult volunteers. Up to 24 participants will receive a single dose of either psilocybin or inert dummy treatment (placebo), and they will be asked to complete several computer-based behavioral tasks measuring features of learning, belief updating, and abstraction.
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin (Usona Institute), or Inactive Placebo (Usona Institute). The registry lists allocation as randomized. The primary aim of this phase I mechanistic pilot study is to measure the effects of psilocybin on aspects of cognition in healthy adult volunteers.
They plan to enroll about 24 people at Providence. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation
Primary outcome (registry wording): Reinforcement Learning and Abstraction Task
Who it is for (from inclusion criteria)
Ages 18 Years to any
be fluent in speaking and reading English
be able to swallow pills (capsules)
be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a clinical interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine laboratory tests
agree to inform investigators within 48 hours of any new medical conditions, treatments, or procedures
agree to refrain from using any psychoactive or recreational drugs, including cannabis, for the duration of study enrollment (with the exception of limited alcohol, nicotine, and caffeine as below)
agree to refrain from drinking alcohol within 24 hours of all experimental sessions
agree to refrain from taking any "as needed" or "over the counter" medications (e.g., medications for pain, insomnia, or allergies) within 24 hours of all experimental sessions, unless previously approved by a study physician
Who the registry excludes
have used any psychedelic, hallucinogen, or entactogen, including 3,4-methylenedioxymethamphetamine (MDMA) and ketamine/esketamine, but not including cannabis, within the past 3 months
unwilling or unable to stop using cannabis a minimum of one week prior to enrollment and to refrain from cannabis use for the duration of the study enrollment, to be tested with urine drug screens
history of traumatic brain injury, or history of seizure disorder in adulthood
baseline QTc \> 450 milliseconds (QTc is defined as the QT interval corrected for heart rate, either machine-read or manually over-read)
current poorly controlled or insulin dependent diabetes mellitus (type I or type II)
current clinically significant respiratory condition (supplemental oxygen requirement, or requiring hospitalization within the last year)
clinically significant renal disease, including but not limited to CKD stage 3 or greater
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
1 listed
Brown University School of Public Health — Providence, Rhode Island (recruiting)
Related recruiting trials in this snapshot
RecruitingNot a traditional drug phaseBethesda, Maryland
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07818564?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07818564?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.