Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Purpose
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Conditions
- Healthy Volunteer
- Older Adults (65-85 Years)
Eligibility
- Eligible Ages
- Between 65 Years and 85 Years
- Eligible Sex
- All
- Accepts 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 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Cohort model: each cohort will receive 2 escalating doses of psilocybin 30 days apart. The first 20 participants will follow this schema: Cohort 1a: Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. If tolerated in the first 20 participants, the second 20 participants will follow this schema: Cohort 1b: Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Psilocybin |
Two escalating doses of psilocybin 30 days apart |
|
Recruiting Locations
San Francisco, California 94158
Aurora, Colorado 80045
Atlanta, Georgia 30329
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
Detailed 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) 30 days apart. - Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart. - Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults. - Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort. Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.