Psilocybin for Aging
(LONG-LIFE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults.
Up to 50 participants will be enrolled aged 60-80 who will be randomized with equal allocation to one of four intervention groups: (1) receipt of one 25 mg dose of psilocybin; (2) receipt of two 25 mg doses of psilocybin separated by four weeks; (3) receipt of three 25 mg doses, with each dose separated by four weeks; or (4) wait-list comparator condition that does not receive psilocybin. Biomarkers of aging, cognitive performance, and behavioral measures will be assessed at baseline and longitudinally over a 12-month follow-up period. The primary endpoint occurs at the Week 16 visit. Participants randomized to the wait-list condition will be offered a single 25 mg dose of psilocybin following conclusion of the 12-month follow-up period.
Findings from this Phase I study will inform dose selection for a Phase II study should results indicate a potential impact of psilocybin on relevant study endpoints.
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive psilocybin doses with therapeutic support, varying by group: one, two, or three doses separated by four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of aging biomarkers and cognitive performance
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
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
Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.
Participants in this arm will not receive psilocybin as part of the main study but will be given the opportunity to receive a single 25mg dose of psilocybin with therapeutic support after their study participation is complete.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Charles Raison
Lead Sponsor
Baylor College of Medicine
Collaborator
Steadman Philippon Research Institute
Collaborator
Emory University
Collaborator
University of Wisconsin, Madison
Collaborator
Usona Institute
Collaborator
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