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

医用大麻对老年人的实时和长期影响：一项前瞻性队列研究

• 批准号: 10560636
• 负责人: Yan Wang
• 金额: $ 59.48万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-15 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10560636
• 关键词: Address; Anxiety; Biological; Biological Aging; Biological Markers; Cell Aging; Cellular Phone; Characteristics; Chemicals; Country; Data; Data Analyses; Dose; Drops; Ecological momentary assessment; Elderly; Ensure; Environment; Equilibrium; Expectancy; Florida; Goals; Guidelines; Health Benefit; Individual Differences; Length; Life; Long-Term Effects; Marijuana; Measurement; Measures; Medical Marijuana; Medical Records; Mental Depression; Outcome; Pain; Pain Research; Pain intensity; Patients; Pattern; Persons; Phenotype; Physical Function; Physical activity; Physicians; Prospective cohort; Prospective, cohort study; Psychological Factors; Quality of life; Research; Resources; Route; Sampling; Sativex; Sleep; Social Desirability; Source; Surveys; Technology; Telomere Shortening; Testing; Time; Visit; chronic pain; cognitive change; cognitive function; comparison group; disability; emotional functioning; fitbit; health related quality of life; improved; improved outcome; in vivo; innovation; male; marijuana use; marijuana user; medical examination; mobile computing; novel; pain reduction; patient subsets; protective factors; randomized trial; recruit; response; sensor; sex; side effect; success; telomere; wearable sensor technology

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.

抽象的 老年人是该国的医用大麻（MM）用户的快速增长的部分 痛苦是最被引用的使用原因。迫切需要系统地检查MM的短期和长期 对核心结果的术语影响，包括疼痛强度，身体，情感和认知功能以及 整体生活质量，并跟踪其在老年人中的副作用（NOT-DA-20-014）。而手机的普遍性 技术提供了一个独特的机会来测量MM使用及其在体内的结果，尚未应用它 在MM和疼痛研究中。此外，我们的研究表明，端粒长度是细胞衰老的量度，是 与慢性疼痛阶段负相关，但没有研究使用端粒长度作为生物标志物 检查MM对老年人生物衰老的长期影响。此外，在为 对MM的差异反应，个体差异（例如，性别，基线疼痛表型，预期）具有 在先前的研究中没有充分探索。为了解决这些差距，我们提出了第一个潜在的 队列研究，创新地结合了基于技术的生态瞬时评估（EMA）和IN- 人们在12个月内访问，以获取有关MM效应的主观和客观数据。主要目标 该项目是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，我们将招募并关注440 老年人（³50岁，50％的男性）患有慢性疼痛，因为有些启动MM（n = 330），而另一些则没有（n = 110）。 主观和客观数据将在面对面访问（基线和12个月）以及通过智能手机中收集 和基于传感器的测量在1、3、6和9个月时爆发。具体目的是：1）确定是否 MM使用会导致疼痛强度水平，身体和情感功能的短期变化 即时的; 2）确定MM使用是否导致12个月内的长期变化，包括疼痛 强度，情感，身体和认知功能，与健康相关的生活质量以及端粒长度；和 3）在启动MM中，检查哪些MM产品特性（即THC：CBD比，给药 路线，剂量）预测目标1和2或更多副作用中定义的结果的更多改善，以及是否是否 个体差异（例如，性别，基线疼痛表型，预期）适应关系。和 实时和12个月内收集的多源数据，我们的结果将有助于所需的大大 科学证据：1）MM是否可以减轻疼痛并改善身体/情绪功能 老年人的期限； 2）MM的影响是否持续12个月并证明生活质量 改善或认知变化； 3）健康益处和后果是否因MM产品类型而有所不同； 4）哪些患者亚组可能会从MM使用中受益更多。