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Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2025 to Nov 2025
    • Site details revised
    v4
  2. Notable Start date: Apr 1, 2025 to Jul 1, 2025v3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 247 words
    • Secondary endpoints: 4 to 33
    • Study description shortened, about 188 words
    • Study arms: 2 to 3
  3. Minor Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 3 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity.
Trial Details
NCT Number NCT06367738
Lead Sponsor University of California, Berkeley
Conditions
(from sponsor)
Aging
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov