40 Participants NeededMy employer runs this trial

Psilocybin for Elderly

(Psil-Pk Trial)

Recruiting at 5 trial locations
MP
LH
Overseen ByLila Harris, BS
Age: 65+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Capacity to Consent
I am between 65 and 85 years old.
Generally healthy
See 1 more

Exclusion Criteria

Family history of psychotic or serious bipolar spectrum illnesses
Primary psychotic or affective psychotic disorders
Extensive use of serotonergic hallucinogens
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two escalating doses of psilocybin 30 days apart

8 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
3 visits (in-person)

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

Group I: PsilocybinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

University of Nebraska

Collaborator

Trials
563
Recruited
1,147,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

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, ...

Safety 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).

The 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 ...