Development of a Longitudinal Observational Research Registry for the Study of Medicinal Cannabis Use and Health

开发药用大麻使用和健康研究的纵向观察研究登记册

• 批准号: 10741486
• 负责人: Johannes Thrul
• 金额: $ 205.9万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10741486
• 关键词: Adverse event; Advertising; Advocate; American; Archives; Area; Cannabinoids; Cannabis; Cannabis policy; Cannabis retail; Caring; Case Study; Characteristics; Clinical Chemistry Tests; Clinical Trials; Computerized Medical Record; Cross-Sectional Studies; Data; Data Collection; Data Sources; Databases; Development; Dose; Ecological momentary assessment; Education; Evaluation; Federal Government; Funding; General Population; Government Agencies; Health; Health Status; Health system; Hemp; Hepatotoxicity; Industry; Injury; Interdisciplinary Study; International; Internet; Knowledge; Label; Legal; Legal Medicine; Local Government; Measures; Medical Marijuana; Medicine; Methods; Modeling; National Institute of Drug Abuse; Natural Language Processing; Observational Study; Online Systems; Outcome; Paper; Patients; Persons; Pharmaceutical Preparations; Pilot Projects; Poison Control Centers; Poisoning; Policies; Policy Maker; Process; Provider; Public Health; Publishing; Quality Control; Random Allocation; Registries; Reporting; Research; Research Methodology; Research Personnel; Research Project Grants; Risk; Route; Scientist; Source; Summary Reports; Surveys; Test Result; Testing; Therapeutic; Therapeutic Uses; United States National Institutes of Health; Work; abuse liability; alternative treatment; clinical decision-making; cohort; computer science; daily functioning; data de-identification; data integration; data mining; data repository; data resource; data sharing; demographics; design; experience; interest; marijuana use; marijuana user; method development; novel; patient registry; patient subsets; poison control; programs; prospective; recruit; symptom management; tool; web site

Due to changes in cannabis policy, most Americans now have access to an array of retail cannabis products. An estimated 5.5 million Americans are registered with state-regulated medical cannabis programs and the therapeutic use of federally legal hemp (e.g. CBD) products is widespread. Despite most states having legalized medicinal cannabis use, little is known about the characteristics of these patients, the cannabis products they use, or the patient-level health impact of their medicinal cannabis use. Filling these gaps in knowledge remains an urgent public health need. We propose to: 1) design and implement a prospective medicinal cannabis patient registry for longitudinal data collection. We will recruit a nationally representative cohort of patients newly initiating the use of cannabis for therapeutic purposes into a longitudinal observational research registry. We will assess patient demographics, cannabis product use, and a range of health outcomes prior to and repeatedly after initiation of medicinal cannabis use via web-based surveys. A subset of patients will complete intensive data collection via ecological momentary assessment (EMA) and/or provide biospecimens for clinical chemistry testing to determine the impact of medicinal cannabis use on daily functioning and symptom management in addition to potential unseen harms such as liver toxicity; 2) Establish a program of medicinal cannabis product testing based on adverse event reporting and other mentions of injury/harm in the patient registry or via surveillance of other data sources (e.g. poison control data, FDA warnings, online forum posts). Products associated with adverse events or other harms will be targeted for testing related to dose-label accuracy, cannabinoid content, and presence of contaminants; 3) Identify and integrate existing sources of data that can inform the health impacts of medicinal cannabis use. This includes electronic medical record (EMR) databases as well as prior and ongoing research projects of the study team (e.g., Realm of Caring Observational Research Registry); 4) Develop and implement a website that will include annual summary reports of the combined data, an application process for researcher access to de-identified data for the conduct of novel analyses, and an archive of published papers related to the health impacts of medicinal cannabis use. A pilot research program to fund scientists interested in probing the data repository will be established. Our team includes internationally recognized expertise in the comprehensive research methods proposed. The result of this project will be a rich data resource for understanding the health impacts of medicinal cannabis use. Data will include patient-level outcomes across a broad range of therapeutic purposes and include use of a variety of cannabis products. Data will help inform clinical decision making related to initiation of cannabis products, guidance on product, route of administration and dose selection, risks related to adverse events, injury/poisoning risk and abuse liability. Findings will also help local and federal government agencies develop effective policies, programs, and regulatory strategies to mitigate harms associated with the rapidly growing cannabis industry.

由于大麻政策的变化，大多数美国人现在可以获得一系列零售大麻产品。 据估计，有 550 万美国人在国家监管的医用大麻计划中注册，并且 联邦合法大麻（例如 CBD）产品的治疗用途非常广泛。尽管大多数州已经合法化 药用大麻的使用，人们对这些患者的特征以及他们使用的大麻产品知之甚少 使用，或使用药用大麻对患者健康的影响。填补这些知识空白仍然存在 紧迫的公共卫生需求。我们建议：1）设计并实施一个潜在的药用大麻患者 纵向数据收集登记处。我们将新招募具有全国代表性的患者队列 启动将大麻用于治疗目的纳入纵向观察研究登记册。我们将 之前和反复评估患者人口统计数据、大麻产品使用情况以及一系列健康结果 通过网络调查开始使用药用大麻后。一部分患者将完成强化治疗 通过生态瞬时评估 (EMA) 收集数据和/或为临床化学提供生物样本 进行测试以确定药用大麻的使用对日常功能和症状管理的影响 除了潜在的看不见的危害，例如肝毒性； 2) 制定药用大麻产品计划 根据不良事件报告和患者登记处或通过其他提及的伤害/伤害进行测试 监视其他数据源（例如毒物控制数据、FDA 警告、在线论坛帖子）。产品 与不良事件或其他危害相关的药物将成为与剂量标签准确性相关的测试的目标， 大麻素含量和污染物的存在； 3) 识别并整合现有的数据源 告知药用大麻使用对健康的影响。这包括电子病历 (EMR) 数据库 以及研究团队之前和正在进行的研究项目（例如，关怀观察研究领域） 登记处）； 4) 开发并实施一个网站，其中包括合并数据的年度总结报告， 研究人员访问去识别化数据以进行新颖分析的申请流程，以及 与药用大麻使用对健康影响相关的已发表论文档案。试点研究计划 将设立有兴趣探索数据存储库的科学家基金。我们的团队包括国际 所提出的综合研究方法得到认可的专业知识。该项目的成果将是丰富的 用于了解药用大麻使用对健康影响的数据资源。数据将包括患者水平 广泛的治疗目的的结果，包括使用各种大麻产品。数据 将有助于为与大麻产品的启动、产品指导、途径相关的临床决策提供信息 给药和剂量选择、与不良事件相关的风险、伤害/中毒风险和滥用责任。 研究结果还将帮助地方和联邦政府机构制定有效的政策、计划和 减轻与快速增长的大麻产业相关的危害的监管战略。