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

基本信息

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
项目类别：
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

项目摘要

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，大多数美国人现在都可以使用一系列零售大麻产品。估计有550万美国人在国家监管的医用大麻计划中注册联邦法律大麻（例如CBD）产品的治疗使用广泛。尽管大多数州合法化使用药用大麻，对这些患者的特征，大麻产品知之甚少使用或使用药用大麻的患者级健康影响。在知识中填补这些空白仍然存在紧急的公共卫生需求。我们建议：1）设计和实施一名前瞻性药用大麻患者纵向数据收集注册表。我们将招募新的代表性患者队列将大麻用于治疗目的的用途启动到纵向观察研究注册中。我们将评估患者人口统计学，大麻产品的使用以及一系列健康结果通过基于Web的调查开始使用药用大麻。一部分患者将完成密集型通过生态瞬时评估（EMA）和/或提供临床化学的生物测量来收集数据测试以确定使用大麻对每日功能和症状管理的影响增加了潜在的看不见的危害，例如肝毒性； 2）建立一个药用大麻产品计划基于不良事件报告以及患者注册中的伤害/伤害的其他提及的测试对其他数据源的监视（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针对与剂量标签准确性相关的测试目标，大麻素含量和污染物的存在； 3）识别并集成了可以告知使用药用大麻的健康影响。这包括电子病历（EMR）数据库以及研究团队的先前和正在进行的研究项目（例如，关怀观察研究领域注册表）; 4）开发并实施一个网站，其中包括合并数据的年度摘要报告，研究人员访问去识别数据的申请过程，用于进行新分析，并与药用大麻的健康影响有关的发表论文档案。试点研究计划有兴趣探索数据存储库的基金科学家将建立。我们的团队包括国际提出的综合研究方法中公认的专业知识。这个项目的结果将是一个富人了解使用药用大麻的健康影响的数据资源。数据将包括患者级各种治疗目的的结果，包括使用各种大麻产品。数据将有助于告知与大麻产品的启动有关的临床决策，产品指南，途径行政和剂量选择，与不良事件有关的风险，伤害/中毒风险和滥用责任。调查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行业相关的危害的监管策略。