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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

RecruitingPhase 1

Sponsor: University of Colorado, Denver

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

Interventions: Psilocybin (Usona Institute)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 65 Years to 85 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (6)

San Francisco, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
New York, New York, United States