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NCT07516405 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
A Phase 1 study, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07516405: Recruiting Phase 1 study, sponsored by University of Colorado, Denver.
NCT07516405 is a Phase 1 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07516405, a Phase 1 study, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Primary Outcome
Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial
Interventions
- DRUG Psilocybin (Usona Institute)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
What NCT07516405 shows while recruiting
NCT07516405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin (Usona Institute) is the first listed.
NCT07516405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07516405 about?
NCT07516405 is a clinical study titled "Safety and Tolerability Trial of Psilocybin in Healthy Older Adults". This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
What is the current status of trial NCT07516405?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-04-01. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07516405?
The interventions under investigation include: Psilocybin (Usona Institute) (DRUG).
Who is sponsoring clinical trial NCT07516405?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07516405's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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