Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Phase 1RecruitingNCT07516405

University of Colorado, Denver40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Older Adults (65-85 Years)

Interventions

Psilocybin (Usona Institute)DRUG

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.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

University of California San Francisco (UCSF) Department of Neurology

San Francisco, California, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

RECRUITING

Emory University Brain Health Center

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Adverse Events

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

Time frame: up to 14 weeks

Secondary Outcomes

Total drug exposure (Area Under the Curve, AUC)

Total drug exposure measured with blood samples - Pharmacokinetics

Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

Elimination Half-life

Elimination Half-life measured with blood samples - Pharmacokinetics

Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

Maximum concentration (Cmax)

Maximum plasma concentration (Cmax) measured with blood samples - Pharmacokinetics

Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

Minimum concentration (Cmin)

Minimum plasma concentration (Cmin) measured with blood samples - Pharmacokinetics

Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

Central Contacts

Mary P Mancuso, MA (dual degrees)

CONTACT

3037245729 inspire@cuanschutz.edu

Lila Harris, BS

CONTACT

lila.m.harris@cuanschutz.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.