Phase 1: testing Psilocybin (Usona Institute) for Healthy Volunteer
This study plans to learn more about the whether it is safe and how hard side effects are to live with of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Official registry: https://clinicaltrials.gov/study/NCT07516405 · University of Colorado, Denver · enrollment listed as 40
What this phase means
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). The registry lists allocation as na. This study plans to learn more about the whether it is safe and how hard side effects are to live with of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
They plan to enroll about 40 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Interventions: Psilocybin (Usona Institute)
Primary outcome (registry wording): Adverse Events
Who it is for (from inclusion criteria)
- Ages 65 Years to 85 Years
- Aged 65-85 years \& be male, female, or non-binary
- Have an identified support person
- Capacity to Consent
Who the registry excludes
- Unstable medical condition
- Risk for hypertensive crisis (screening blood pressure \>140/90 mmHg)
- Significant central nervous system (CNS) pathology
- Primary psychotic or affective psychotic disorders
- Family history of psychotic or serious bipolar spectrum illnesses
- High risk of adverse emotional or behavioral reaction
- Active substance use disorders (SUDs)
Public study contact (from the registry)
Mary P Mancuso, MA (dual degrees)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
6 listed- University of California San Francisco (UCSF) Department of Neurology — San Francisco, California (recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado (recruiting)
- Emory University Brain Health Center — Atlanta, Georgia (recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts (recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska (recruiting)
- New York University Langone Health, Center for Psychedelic Medicine — New York, New York (recruiting)
FAQ about this NCT record
Is NCT07516405 still recruiting?
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 NCT07516405?
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 NCT07516405?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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