Real-Time and Long-Term Effects of Medical Marijuana on Older Adults: A Prospective Cohort Study

摘要 老年人代表着这个国家快速增长的医用大麻(MM)使用者群体，他们患有慢性 疼痛是最常被引用的使用理由。迫切需要系统地研究MM的短期和长期... 对核心结果的长期影响，包括疼痛强度、身体、情感和认知功能，以及 总体生活质量，并追踪其在老年人中的副作用(非-DA-20-014)。而移动设备的无处不在 技术提供了一个独特的机会来衡量MM的使用及其在体内的结果，它尚未被应用 多发性硬化症和疼痛研究。此外，我们的研究表明，端粒长度，一种衡量细胞衰老的指标， 与慢性疼痛分期呈负相关，但还没有研究使用端粒长度作为生物标志物 研究MM对老年人生物老化的长期影响。此外，在为 对MM的不同反应，个体差异(例如，性别、基线疼痛表型、预期)有 在以前的研究中没有得到充分的探索。为了解决这些差距，我们提出了第一个预期 队列研究，创新性地结合了基于技术的生态瞬时评估(EMA)和在- 个人访问超过12个月，以获得关于MM疗效的主观和客观数据。的主要目标 本项目旨在1)确定MM对疼痛、身体、情感和认知的短期和长期影响 老年人的功能和生活质量，以及2)确定MM的产品特征和患者亚组 与改善的结果或副作用有关。为了实现这些目标，我们将招募和跟踪440名员工 患有慢性疼痛的老年人(50岁，男性占50%)，一些人会引发多发性骨髓瘤(n=330)，另一些人则不会(n=110)。 主观和客观数据将在面对面访问(基线和12个月)和通过智能手机收集- 而基于传感器的测量在1、3、6和9个月时爆发。具体目标是：1)确定是否 使用MM会导致疼痛强度水平的短期变化，身体和情绪功能以 实时；2)确定MM的使用是否会在12个月内导致长期变化，包括疼痛 强度、情绪、身体和认知功能、与健康相关的生活质量和端粒长度； 3)在发起MM的人中，检查哪些MM的产品特征(即THC：CBD比率、给药 路径、剂量)预测AIMS 1和2中定义的结果的更多改善或更多副作用，以及是否 个体差异(例如，性别、基线疼痛表型、预期)缓和了这种关系。使用 实时收集超过12个月的多源数据，我们的结果将有助于极大地满足 关于以下方面的科学证据：1)MM是否能减轻疼痛，改善身体/情绪功能 2)MM的影响是否持续12个月并表现出生活质量 改善或认知改变；3)MM产品类型是否对健康有益和后果不同； 哪一类患者可能从MM的使用中获益更多。

ABSTRACT Older adults represent a fast-growing segment of medical marijuana (MM) users in this country, with chronic pain as the most cited reason for use. There is a critical need to systematically examine MM’s short- and long- term effects on the core outcomes including pain intensity, physical, emotional, and cognitive functioning, and overall quality of life, and to track its side effects in older adults (NOT-DA-20-014). While the ubiquity of mobile technology provides a unique opportunity to measure MM use and its outcomes in vivo, it has not been applied in MM and pain research. In addition, our research shows that telomere length, a measure of cellular aging, is negatively associated with chronic pain stage, but no study has used telomere length as a biomarker to examine MM’s long-term effects on biological aging in older adults. Further, while contributing to the differentiated response to MM, individual differences (e.g., sex, baseline pain phenotyping, expectancy) have not been adequately explored in prior research. To address these gaps, we propose the first prospective cohort study that innovatively combines technology-based ecological momentary assessments (EMA) and in- person visits over 12 months to obtain both subjective and objective data on MM’s effects. The main goals of this project are to 1) determine MM’s short- and long-term effects on pain, physical, emotional, and cognitive functioning, and quality of life in older adults, and 2) identify MM product characteristics and patient subgroups associated with improved outcomes or side effects. To accomplish these goals, we will recruit and follow 440 older adults (³ 50 years, 50% male) with chronic pain as some initiate MM (n=330) and other do not (n=110). Subjective and objective data will be collected at in-person visits (baseline & 12 months) and via smartphone- and sensor-based measurement bursts at 1, 3, 6, and 9 months. The specific aims are: 1) Determine whether MM use leads to short-term changes in pain intensity level, physical and emotional functioning measured in real-time; 2) Determine whether MM use leads to longer-term changes over 12 months, including pain intensity, emotional, physical, and cognitive functioning, health-related quality of life, and telomere length; and 3) Among those initiating MM, examine which MM product characteristics (i.e., THC:CBD ratio, administration route, dose) predict more improvements in outcomes defined in Aims 1&2 or more side effects, and whether individual differences (e.g., sex, baseline pain phenotyping, expectancy) moderate the relationship. With multisource data collected in real-time and over 12 months, our results will contribute to the greatly needed scientific evidence on: 1) whether MM can reduce pain and improve physical/emotional functioning in short term among older adults; 2) whether effects of MM last for 12 months and demonstrate quality of life improvements or cognitive changes; 3) whether health benefits and consequences differ by MM product type; and 4) which subgroups of patients may benefit more from MM use.