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Recruiting NCT07516405

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Phase I Interventional Healthy Volunteer Older Adults (65-85 Years)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin (Usona Institute).
Who it may be relevant to
Registry conditions: Healthy Volunteer, Older Adults (65-85 Years). Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Overview

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

  • Drug Psilocybin (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.

Primary outcome measures

  • Adverse Events [Time frame: up to 14 weeks]
Secondary outcome measures (4)
  • Total drug exposure (Area Under the Curve, AUC) [Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)]
  • Elimination Half-life [Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)]
  • Maximum concentration (Cmax) [Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)]
  • Minimum concentration (Cmin) [Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • University of California San Francisco (UCSF) Department of Neurology — San Francisco
  • University of Colorado Anschutz Medical Campus — Aurora
  • Emory University Brain Health Center — Atlanta
  • Dana-Farber Cancer Institute — Boston
  • University of Nebraska Medical Center — Omaha
  • New York University Langone Health, Center for Psychedelic Medicine — New York

Identifiers

NCT: NCT07516405 · 25-2070 · UG3AG094957

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗