An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16
研究概览
简要总结
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.
详细描述
Aging is accompanied by progressive changes across multiple physiological systems that contribute to functional decline and increased risk for age-related disease. Biomarkers of biological aging, including DNA methylation-based epigenetic clocks, have emerged as tools for assessing age-related biological processes and predicting future health outcomes.
Recent preclinical studies have suggested that psilocybin and its active metabolite, psilocin, may influence several pathways implicated in aging, including cellular senescence, oxidative stress, neuroplasticity, and epigenetic regulation. In addition to biological effects, observational studies have demonstrated associations between psychosocial factors, including purpose in life and social connectedness, and reduced morbidity and mortality in older adults. Previous clinical studies have shown that psilocybin may produce changes in psychological well-being, meaning, and related constructs.
The LONG-LIFE Study is designed to evaluate multiple domains relevant to healthy aging, including, but not limited to, epigenetic and biological clock measures, cognitive performance, psychosocial well-being, and ecological momentary assessments of daily experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Two 25mg Doses of Psilocybin
Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
干预措施: Psilocybin (Usona Institute) (Drug)
Wait-list Comparator
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.
One 25mg Dose of Psilocybin
Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.
干预措施: Psilocybin (Usona Institute) (Drug)
Three 25mg Doses of Psilocybin
Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
干预措施: Psilocybin (Usona Institute) (Drug)
结局指标
主要结局
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16
时间窗: Change from Baseline to Week 4 and Week 16
Epigenetic/biological clock profiles; change from Baseline to Week 4 and 16
Change in Purpose in Life (PIL) from Baseline to Week 4 and Week 16
时间窗: Change 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).
次要结局
- Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52(Change from Baseline to Week 52)
- Change in Telomere Length from Baseline to Week 52(Change from Baseline to Week 52)
- Change in Purpose in Life (PIL) from Baseline to Week 52(Change from Baseline to Week 52)
- Change in Satisfaction with Life from Baseline to Week 4 and Week 16(Change from Baseline to Week 4 and Week 16)
- Change in Wellbeing from Baseline to Week 4 and Week 16(Change from Baseline to Week 4 and Week 16)
- Change in Optimism from Baseline to Week 4 and Week 16(Change from Baseline to Week 4 and Week 16)
- Change in Perceived Control/Mastery from Baseline to Week 4 and Week 16(Change from Baseline to Week 4 and Week 16)
- Change in Loneliness from Baseline to Week 4 and Week 16(Change from Baseline to Week 4 and Week 16)
研究者
Charles Raison
Director, Vail Health Behavioral Health Innovation Center
Vail Health Behavioral Health