NCT07516405 · University of Colorado, Denver
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
(Psil-Pk)
What this study is about
This study plans to learn more about the safety and how well patients handle the treatment of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
View original scientific description
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
- Aurora, Colorado
- Atlanta, Georgia
- Boston, Massachusetts
- Omaha, Nebraska
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations