A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
University of Colorado, Denver
Summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Description
The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing. * Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg)…
Eligibility
- Age range
- 65–85 years
- Sex
- All
- Healthy volunteers
- Yes
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 ri…
Interventions
- DrugPsilocybin (Usona Institute)
Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. * Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
Locations (6)
- University of California San Francisco (UCSF) Department of NeurologySan Francisco, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Emory University Brain Health CenterAtlanta, Georgia
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Nebraska Medical CenterOmaha, Nebraska
- New York University Langone Health, Center for Psychedelic MedicineNew York, New York