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Tests treatment safety and results for Healthy Volunteer
Official title Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
ClinicalTrials.gov ID: NCT07516405
What this study is testing
What is Psilocybin (Usona Institute)?
Psilocybin (Usona Institute) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Aged 65-85 years \& be male, female, or non-binary
- Generally healthy
- Have an identified support person
- Capacity to Consent
You likely can't join if
- 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
See the full eligibility criteria
- Aged 65-85 years \& be male, female, or non-binary
- Generally healthy
- Have an identified support person
- Capacity to Consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.