Psilocybin for Elderly
(Psil-Pk Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates the safety of psilocybin, a psychedelic substance, in healthy older adults. Researchers aim to assess how well adults aged 65-85 tolerate psilocybin when given in two increasing doses 30 days apart. The trial seeks participants who are generally healthy and have a support person available if needed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including those that affect serotonin in the brain, antipsychotics, some mood stabilizers, and specific enzyme inhibitors. If you're on any of these, you may need to stop them before participating.
Is there any evidence suggesting that psilocybin is likely to be safe for humans?
Research shows that psilocybin is generally safe and well-tolerated in older adults when used in controlled settings. Studies have found few serious side effects, and most people don't experience major issues. A review of clinical trials suggests that psilocybin can be safe for healthy older adults. Previous studies on older individuals have shown promising results for safety and tolerance.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for elderly patients, which often includes antidepressants or anxiolytics, psilocybin offers a unique approach by utilizing a psychedelic compound found in certain mushrooms. Researchers are excited about psilocybin because it has the potential to rapidly reduce symptoms of depression and anxiety, often with just one or two doses, whereas traditional medications can take weeks to show effects. Additionally, psilocybin targets serotonin receptors in a novel way, potentially leading to long-lasting changes in mood and cognition, which is a promising alternative to the ongoing use of conventional medications.
What evidence suggests that psilocybin might be an effective treatment for elderly patients?
Research has shown that psilocybin, a compound in certain mushrooms, may improve mental health issues like depression and anxiety, especially with psychological support. For older adults, studies have observed improved mood and overall well-being. One study suggested that psilocybin might slow aging by affecting cellular function. Another study highlighted its potential to extend cell life and boost brain function. While more research is needed, these findings suggest psilocybin could enhance the quality of life for older adults. Participants in this trial will receive two escalating doses of psilocybin, 30 days apart, to further explore these potential benefits.16789
Are You a Good Fit for This Trial?
This trial is for generally healthy adults aged 65-85 who can give consent and have a support person. People with certain mental health conditions, unstable medical issues, recent hallucinogen use, or high blood pressure cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two escalating doses of psilocybin 30 days apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study is testing the safety and tolerability of psilocybin (a psychedelic compound) in healthy older adults. Participants will receive psilocybin under supervision to monitor its effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Two escalating doses of psilocybin 30 days apart
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
NYU Langone Health
Collaborator
University of Nebraska
Collaborator
University of California, San Francisco
Collaborator
Emory University
Collaborator
Dana-Farber Cancer Institute
Collaborator
Citations
Safety and Tolerability Trial of Psilocybin in Healthy Older ...
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85. Detailed ...
Psychedelic interventions for major depressive disorder in the ...
Psilocybin with psychological support resulted in rapid, sustained reductions in depressive symptoms, without serious adverse events, suggesting ...
Psilocybin delays aging, extends lifespan, new Emory study ...
While traditionally researched for its mental health benefits, this study suggests that psilocybin impacts multiple hallmarks of aging by ...
Effects of Psychedelics in Older Adults: A Prospective ...
Older adults reported well-being improvements similar to a matched sample of younger adults following participation in a psychedelic retreat, despite ...
Psilocybin treatment extends cellular lifespan and ...
Psilocin treatment (10 μM) resulted in a 29% extension of cellular lifespan, characterized by delayed exhaustion of proliferative potential, ...
6.
ctv.veeva.com
ctv.veeva.com/study/safety-and-tolerability-trial-of-psilocybin-in-healthy-older-adultsSafety and Tolerability Trial of Psilocybin in Healthy Older Adults
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Effects of Psychedelics in Older Adults: A Prospective Cohort ...
Affective symptoms such as anxiety, low mood, and loneliness are prevalent and highly debilitating symptoms among older adults (OA).
8.
aagponline.org
aagponline.org/wp-content/uploads/2023/09/JohnstonAnderson-et-al-2023_Psychedelic-Assisted-Therapies-for-Older-Adults.pdfThe Safety and Efficacy of Psychedelic-Assisted Therapies ...
While the controlled use of psilocybin and MDMA have been associated with few severe adverse reac- tions, and almost no serious adverse ...
The Safety and Efficacy of Psychedelic-Assisted Therapies ...
Although published research on psychedelic medications has suggested that they are relatively safe when given in controlled conditions, few older people with ...
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