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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

University of Colorado, Denver · with National Institute on Aging (NIA), University of California, San Francisco · NCT07516405

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
40
US sites recruiting
6
Study start
April 1, 2026
Record last updated
September 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

Being studied: Psilocybin (Usona Institute)

Conditions: Healthy Volunteer; Older Adults (65-85 Years)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Aged 65-85 years \& be male, female, or non-binary
  • Generally healthy
  • Have an identified support person
  • Capacity to Consent

Exclusion Criteria

  • 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)
  • Extensive use of serotonergic hallucinogens
  • High risk of completed suicide
  • History of hallucinogen persisting perception disorder (HPPD)
  • Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10
  • Certain psychiatric conditions
  • Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study

Recruiting US locations

  • University of California San Francisco (UCSF) Department of Neurology

    San Francisco, CA 94158

    Site contact: Jennifer Mitchell, PhD · 510-985-3522 · psy.elder@ucsf.edu

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Mary Mancuso, MS · 303-724-5729 · inspire@cuanschutz.edu

  • Emory University Brain Health Center

    Atlanta, GA 30329

    Site contact: Tanja Mletzko, MA · 404-778-6663 · study@emory.edu

  • Dana-Farber Cancer Institute

    Boston, MA 02215

    Site contact: Gabriel Najarian · patresearch@dfci.harvard.edu

  • University of Nebraska Medical Center

    Omaha, NE 68105

    Site contact: Jennifer Wettschreck, MS · 402-559-3342 · jemurray@unmc.edu

  • New York University Langone Health, Center for Psychedelic Medicine

    New York, NY 10016

    Site contact: Denise Balili, MS · 646-501-2623 · denise.balili@nyulangone.org

Study contacts (from the official record)

  • Mary P Mancuso, MA (dual degrees) · 3037245729 · inspire@cuanschutz.edu
  • Lila Harris, BS · lila.m.harris@cuanschutz.edu
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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults (NCT07516405) | Bored Studies