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Psilocybin Safety Tolerability Healthy Older Adults Study

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Summary

The National Institutes of Health registered a clinical trial (NCT07516405) evaluating psilocybin safety and tolerability in healthy older adults. The study will assess how this psychedelic compound is tolerated in subjects aged 60-85. Clinical trial sponsors and researchers should ensure proper registration and protocol compliance.

What changed

A new clinical trial registration appeared on ClinicalTrials.gov documenting a study on psilocybin safety and tolerability in healthy older adults (NCT07516405). The registration includes study objectives focused on evaluating how the psychedelic compound is tolerated in subjects aged 60-85.

Clinical trial sponsors, research institutions, and investigators involved in psychedelic medicine research should monitor this trial's progress. While the registration itself does not create immediate compliance obligations, studies involving Schedule I substances must maintain proper DEA licensing, IRB oversight, and FDA regulatory compliance throughout the research lifecycle.

What to do next

  1. Monitor ClinicalTrials.gov for protocol details and enrollment updates
  2. Verify proper DEA Schedule I handling procedures if involved in psychedelic research
  3. Track IRB approvals and FDA regulatory pathway for study progress

Archived snapshot

Apr 9, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07516405

Who this affects

Applies to
Healthcare providers Pharmaceutical companies
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Human subjects research Drug safety study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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