Psilocybin for Aging

(LONG-LIFE Trial)

BS
Overseen ByBHIC Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Charles Raison
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 explores whether psilocybin, a compound in certain mushrooms, can affect aspects of aging such as mental sharpness and life satisfaction in older adults. Participants will receive one, two, or three doses of psilocybin, or join a group that does not receive it immediately. Researchers aim to determine how different doses impact aging markers and cognitive function over a year. The trial seeks medically stable individuals aged 60-80 interested in enhancing their cognitive health and sense of purpose. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin can be safe and well-tolerated in older adults. Some studies have found that psilocybin might raise blood pressure and heart rate, but this usually concerns only those with heart problems. Safety data indicate that older adults in psilocybin-assisted therapy generally handled it well.

One study showed that the Food and Drug Administration (FDA) considers psilocybin to have a good safety profile, meaning it usually has only minor side effects. However, monitoring for any possible reactions remains important, especially in older adults.

Overall, while psilocybin appears safe for many, discussing any concerns with a healthcare provider is always advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about psilocybin for aging because it offers a novel approach compared to traditional treatments like antioxidants or hormone replacement therapies. Unlike these treatments, psilocybin, a compound found in certain mushrooms, works by targeting the brain's serotonin receptors, potentially enhancing mood and cognitive function in a way that standard treatments do not. Additionally, psilocybin's effects can be felt relatively quickly, often within hours, and may offer lasting benefits after just one to three doses, which is a promising contrast to the longer timelines required by other aging-related therapies.

What evidence suggests that this trial's treatments could be effective for aging-related biomarkers and cognitive function?

This trial will explore the effects of psilocybin on aging, with participants receiving different dosing regimens. Research suggests that psilocybin might positively affect aging. Studies have shown that psilocybin can help cells live longer and repair their DNA, which are crucial for slowing down aging. In experiments, psilocybin also reduced cellular damage caused by oxidative stress over time. Animal studies found that psilocybin treatment increased lifespan, even when started later in life. Additionally, evidence indicates that psilocybin might support brain health by promoting changes that counteract typical aging effects. These findings suggest that psilocybin could potentially help older adults by addressing several key aspects of aging.34678

Are You a Good Fit for This Trial?

This trial is for adults aged 60-80 who are medically healthy, can speak English, and have no major medical or psychiatric conditions. Participants must be able to stop certain medications if needed and have a normal heart test (ECG).

Inclusion Criteria

English speaking and able to provide informed consent and complete study procedures
Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject

Exclusion Criteria

Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator
Abnormal ECG at screening that may increase risk during participation, including prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician
History or presence of any psychiatric or medical condition that could pose a safety risk, interfere with participation, or confound study results, as judged by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin doses with therapeutic support, varying by group: one, two, or three doses separated by four weeks

8-12 weeks
3-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of aging biomarkers and cognitive performance

12 months
Longitudinal assessments

Wait-list Comparator Follow-up

Participants in the wait-list group receive a single 25 mg dose of psilocybin with therapeutic support after the 12-month follow-up

Post-study

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

The study tests different doses of psilocybin (one, two, or three doses) versus no treatment in older adults to see how it affects aging markers, thinking skills, and sense of purpose over one year. Groups are chosen at random.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Two 25mg Doses of PsilocybinExperimental Treatment1 Intervention
Group II: Three 25mg Doses of PsilocybinExperimental Treatment1 Intervention
Group III: One 25mg Dose of PsilocybinExperimental Treatment1 Intervention
Group IV: Wait-list ComparatorActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Charles Raison

Lead Sponsor

Trials
1
Recruited
140+

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

Steadman Philippon Research Institute

Collaborator

Trials
11
Recruited
700+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

Usona Institute

Collaborator

Trials
18
Recruited
1,100+

Citations

Psilocybin treatment extends cellular lifespan and improves ...

We demonstrate that psilocin/psilocybin treatment extends both cellular and animal lifespan (even when treatment is initiated late in life). An ...

Psilocybin delays aging, extends lifespan, new Emory study ...

psilocybin impacts multiple hallmarks of aging by reducing oxidative stress, improving DNA repair responses, and preserving telomere length.

Psilocybin in Older Adults: Therapeutic Opportunities in ...

psilocybin administration increased survival in aged animals and extended cellular lifespan, effects associated with reduced oxidative stress, preservation of ...

Can Psilocybin Promote Successful Aging? Q&A with ...

There's evidence that psychedelics cause structural brain changes in the opposite direction of those that often occur with aging. BCSP: Why is ...

Psilocybin in Healthy Older Adults

The Psilocybin Healthy Older Adults Study is a Phase 1 trial examining the safety and pharmacokinetic characteristics of psilocybin in healthy older adults, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38240068/

Older adults in psychedelic-assisted therapy trials

Conclusions: While existing data in older adults is limited, it suggests that psychedelic-assisted psychotherapy can be safe and well tolerated ...

The Safety and Efficacy of Psychedelic-Assisted Therapies ...

However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease. Very ...

Tripping into old age: Can psychedelics protect the aging brain?

UC Berkeley researchers are investigating whether psilocybin can support healthy aging by boosting plasticity in the brains of older adults.