Safety and Tolerability Trial of Psilocybin in Healthy Older Adults (Psil-Pk)

University of Colorado Denver (CU Denver)

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteer

Older Adults (65-85 Years)

Treatments

Drug: Psilocybin (Usona Institute)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07516405

25-2070

UG3AG094957 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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