Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-80
SponsorCharles Raison
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results.
Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).
Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator.
Trial design
Treatments tested in this trial
- Psilocybin (Usona Institute)
Treatment groups
50 Participants
are divided into 4 treatment groupsSponsors and collaborators
Charles Raison
Lead sponsor
Vail Health Behavioral Health
Sponsor institution
Baylor College of Medicine
Collaborator
Steadman Philippon Research Institute
Collaborator
Emory University
Collaborator
University of Wisconsin, Madison
Collaborator
Usona Institute
Collaborator
Source ClinicalTrials.gov