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NCT07516405
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Conditions: Healthy Volunteer, Older Adults (65-85 Years)
Sex: All
Ages: 65 Years – 85 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: University of Colorado, Denver
Location: University of California San Francisco (UCSF) Department of Neurology San Francisco California
Summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Eligibility 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
Source: ClinicalTrials.gov (NCT07516405). StuddyBuddy aggregates publicly available trial information.