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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Psilocybin (Usona Institute)
Drug25mg capsule of psilocybin
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: One 25mg Dose of PsilocybinExperimental treatment 1 intervention
Group B: Two 25mg Doses of PsilocybinExperimental treatment 1 intervention
Group C: Three 25mg Doses of PsilocybinExperimental treatment 1 intervention
Group D: Wait-list ComparatorNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16
Epigenetic/biological clock profiles; change from Baseline to Week 4 and 16
Time frame
Change from Baseline to Week 4 and Week 162
Change in Purpose in Life (PIL) from Baseline to Week 4 and Week 16
Change from baseline in Purpose in Life score measured using the 7-item Purpose in Life Scale (PIL) from the Health and Retirement Study (score range 1-6; higher scores indicate greater purpose in life).
Time frame
Change from Baseline to Week 4 and Week 16Secondary outcomes
1
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52
Change in Epigenetic/biological clock profile from Baseline to Week 52
Time frame
Change from Baseline to Week 522
Change in Telomere Length from Baseline to Week 52
Time frame
Change from Baseline to Week 523
Change in Purpose in Life (PIL) from Baseline to Week 52
Change from baseline in Purpose in Life score measured using the 7-item Purpose in Life Scale (PIL) from the Health and Retirement Study (score range 1-6; higher scores indicate greater purpose in life).
Time frame
Change from Baseline to Week 524
Change in Satisfaction with Life from Baseline to Week 4 and Week 16
Measured using the Satisfaction With Life Scale (SWLS). Scores range from 5 to 35, where higher scores indicate greater satisfaction with life.
Time frame
Change from Baseline to Week 4 and Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options: