Healthy Volunteer, Older Adults (65-85 Years)
Conditions
Keywords
healthy older adults ages 65-85, psilocybin safety, psilocybin tolerability
Brief summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
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.
Interventions
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.
Sponsors
University of Colorado, Denver
National Institute on Aging (NIA)
University of California, San Francisco
Emory University
Dana-Farber Cancer Institute
NYU Langone Health
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 14 weeks | Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total drug exposure (Area Under the Curve, AUC) | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) | Total drug exposure measured with blood samples - Pharmacokinetics |
| Elimination Half-life | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) | Elimination Half-life measured with blood samples - Pharmacokinetics |
| Maximum concentration (Cmax) | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) | Maximum plasma concentration (Cmax) measured with blood samples - Pharmacokinetics |
| Minimum concentration (Cmin) | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) | Minimum plasma concentration (Cmin) measured with blood samples - Pharmacokinetics |
Countries
United States
Contacts
CONTACTMary P Mancuso, MA (dual degrees)
CONTACTLila Harris, BS
Outcome results
None listed