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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

{ "Safety Study of Psilocybin in Healthy Older Adults", "This study is looking at how safe and tolerable psilocybin is for healthy adults aged 65 to 85. Psilocybin is a psychedelic compound. Researchers want to understand its effects on the body and mind, including blood pressure, heart rhythm, and mood. They will also see how your body processes psilocybin and if it affects thinking, memory, or overall well-being. Participants will receive two doses of oral psilocybin, 30 days apart. There are two groups: one receiving moderate doses (10mg then 25mg) and another receiving higher doses (15mg then 30mg). The main goal is to check for any side effects. This study is currently unclear on its recruitment status.", "design": "This is an interventional study with 40 healthy older adults, divided into two groups receiving different doses of psilocybin.", "commitments": "You would receive two doses of oral psilocybin, 30 days apart, and be monitored for up to 14 weeks for any side effects.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for adverse events for up to 14 weeks after the first dose.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07516405

Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Recruiting
PHASE1Ages 65–85InterventionalTreatment
University of Colorado, Denver
~40 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Psilocybin (Usona Institute)

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over up to 14 weeks

Conditions

Healthy Volunteer
Older Adults (65-85 Years)

Explore related trials

Healthy Volunteer

Where it's being run

6 sites across 6 states
California1
Colorado1
Georgia1
Massachusetts1
Nebraska1
New York1

Who to contact

Mary P Mancuso, MA (dual degrees)
[email protected]
3037245729
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 65-85 years \& be male, female, or non-binary
Generally healthy
Have an identified support person
Capacity to Consent

Exclusion

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

What this trial measures

  • Adverse Eventsup 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