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: 10365158
• 负责人: Yan Wang
• 金额: $ 61.58万
• 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/10365158
• 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; Surveys; Technology; Telomere Shortening; Testing; Time; Visit; base; biological sex; 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; mobile computing; novel; pain reduction; patient subsets; 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.

摘要 老年人代表了这个国家医用大麻（MM）使用者中快速增长的部分， 疼痛是使用的最常见原因。有一个关键需要系统地检查MM的短期和长期- 对核心结局的长期影响，包括疼痛强度、身体、情绪和认知功能，以及 总体生活质量，并跟踪其在老年人中的副作用（NOT-DA-20-014）。虽然移动的无处不在 该技术提供了一个独特的机会来测量MM的使用及其在体内的结果，但尚未应用于 在MM和疼痛研究中。此外，我们的研究表明，端粒长度，细胞衰老的衡量标准， 与慢性疼痛阶段呈负相关，但没有研究使用端粒长度作为生物标志物， 研究MM对老年人生物衰老的长期影响。此外，虽然有助于 对MM的不同反应，个体差异（例如，性别、基线疼痛表型、预期） 在以前的研究中没有得到充分的研究。为了解决这些差距，我们提出了第一个前景 队列研究，创新地结合了基于技术的生态瞬时评估（EMA）和 一个人访问超过12个月，以获得主观和客观数据的MM的影响。的主要目标 这个项目是1）确定MM对疼痛，身体，情绪和认知的短期和长期影响 功能和老年人的生活质量，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相关。为了实现这些目标，我们将招募并跟踪440名 患有慢性疼痛的老年人（≥ 50岁，50%男性），一些人开始MM（n=330），另一些人则没有（n=110）。 主观和客观数据将在亲自访问（基线和12个月）和通过智能手机收集- 以及在1、3、6和9个月时的基于传感器的测量突发。具体目标是：（1）确定是否 MM使用导致疼痛强度水平、身体和情绪功能的短期变化， 实时; 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，情绪，身体和认知功能，健康相关的生活质量和端粒长度;以及 3)在那些发起MM的人中，检查哪些MM产品特性（即，THC：CBD比率，管理 途径，剂量）预测目标1和2中定义的结局改善更多或更多副作用，以及是否 个体差异（例如，性别、基线疼痛表型、期望值）调节该关系。与 我们的研究结果将有助于我们在12个月内实时收集的多光谱数据， 科学证据：1）MM是否可以减轻疼痛并改善身体/情绪功能 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产品类型而异; 和4）哪些患者亚组可能从MM使用中获益更多。