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Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Testing psilocybin safety in healthy older adults.

Recruiting
65-85 years
All
Phase 1

This study is designed to see if psilocybin, a psychedelic compound, is safe for older adults aged 65 to 85. **Psilocybin** is a substance that can cause changes in mood, thinking, and perception. The trial will evaluate how psilocybin affects the body, including blood pressure and heart rhythm. Participants will take two doses of psilocybin 30 days apart. There are two groups receiving different doses: a moderate dose (10mg and then 25mg) and a high dose (15mg and then 30mg). The study will also explore how the body absorbs and processes psilocybin and its impact on thinking and well-being.

  • The study involves two visits for dosing, 30 days apart.
  • Participants must be healthy and aged 65-85.
  • People with certain medical or psychological conditions cannot participate.

To be eligible, participants should not have unstable health conditions or a high risk of blood pressure issues. They should not have any history of serious mental illnesses or active substance use disorders. The study seeks to ensure the safety and well-being of participants by carefully selecting eligible individuals.

Study details
    Healthy Volunteer
    Older Adults (65-85 Years)

NCT07516405

University of Colorado, Denver

27 June 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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