A Study of Psilocybin Safety in Healthy Older Adults
This study wants to learn how safe psilocybin is for healthy older adults and how their bodies and minds react to it. We also want to see how psilocybin affects mood, thinking, and well-being.
Why this Research Matters
As people get older, their bodies can respond to medicines in different ways. Psilocybin, a psychedelic drug, has mostly been studied in younger adults, so there is less known about how safe it is for older adults. The goal is to better understand how older adults respond to psilocybin, so studies can be done more safely.
What to Expect
If you join this study, you will first have a screening visit. At this visit, your health history will be reviewed. You will have health checks such as blood and urine tests, a physical exam, heart tests, and assessments of mood and thinking. At each medication visit, you will be given psilocybin. You will get a lower dose first and a higher dose later. Some people will get a first dose of 10 mg, followed by a second dose of 25 mg. Other people will get a first dose of 15 mg, followed by a second dose of 30 mg. You will not know which group you are in. You will also have a safety check-in the day after each medication visit by phone or video. Before your first medication visit, you will have preparation visits. After each medication visit, you will have integration visits with the study team. These visits will last about 1.5 hours and give you time to get ready for or talk about your experience, how you are feeling, and any changes you notice. During the study, your health and safety will be checked through exams and brain tests, and the study team will check in with you about your health, medications, and any side effects you may have. You will also be asked to take short surveys between visits.
Study Duration
If you can join this study, you will take part in about 16 study visits over about 3 and a half months. Some visits will be in person, and others will be done by phone or video. You will have 2 medication visits, which take place 30 days apart.
Who can Participate
You may be able to join this study if you are between 65 and 85 years old and are healthy. You must have a support person who can take you home after each medication visit and be able to help you if needed, and you must have no psilocybin use in the previous 12 months or over 25 uses in a lifetime. The study team will review your health history and screening test results to see if the study is safe for you to join.
Study ID
Protocol Number: 25-2070
Compensation Information
Meet the Team
Principal Investigator