Medical Marijuana Program Participation and Changes in Controlled Substance Use

项目总结： 美国正在经历前所未有的阿片类药物过量死亡率，此前 在过去的20年里，阿片类止痛药的使用急剧上升。作为回应，疾控中心、几个州和 专业组织已经推广了非阿片类药物替代止痛的处方指南 (即消炎药、抗抑郁剂)。更多的重点放在减少 同时使用镇静剂(即苯二氮卓类药物)和其他受管制物质(即 催眠药、肌肉松弛药)协同增加致命过量的风险，特别是在医学上 受威胁的人。最近的报告表明，拥有医用大麻计划的州 阿片类药物过量死亡率。降低过量服药率的可能机制包括减少阿片类药物 因焦虑或失眠症状缓解而使用和/或使用镇静剂。 然而，人们对参与医用大麻项目之间的关系知之甚少 有疼痛情况和改变使用方式的患者使用受控物质。我们所知的更少 关于医用分配的特定大麻素产品的不同影响(如 四氢大麻酚[THC]与高大麻二酚[CBD]产品的比较)。 纽约州医用大麻计划(2016年1月实施)是最高级别的 在美国实施的受监管和医疗化的项目。国家许可的药房必须是 配备有执照的药剂师，并证明他们分发的产品含有一致的大麻素 比例(包括高THC、高CBD和1：1 THC：CBD产品)。因此，纽约州是一个理想的州 为严格分析医用大麻方案的参与和大麻素的影响而设置 在慢性疼痛患者中，随着时间的推移，具有不同THC：CBD比率的受控物质使用的产品。我们 建议与纽约最大的医用大麻提供商(&>；10,000名参与者注册为 2017年10月)。参与者的活动通过电子健康记录进行跟踪，其中包括未确认身份的患者 基线特征(人口统计数据、符合条件的条件和症状、伴随药物) 通过州处方链接到包含12个月受控物质处方历史的数据 药物监测计划(PDMP)。对这些不确定的、汇编的记录的分析是一种高度创新的 和成本效益的方法，以更好地了解如何参与医疗的潜在机制 大麻计划影响疼痛患者的受控物质使用和过量使用风险 接受阿片类药物和镇静催眠药的情况，并可以为后续的前瞻性研究设计提供信息。

Project Summary: The United States is experiencing an unprecedented rate of opioid-related overdose death following a dramatic rise in opioid painkiller use over the past 20 years. In response, the CDC, several states, and professional organizations have promoted prescriber guidelines for managing pain with non-opioid alternatives (i.e., anti-inflammatories, anti-depressants). Additional emphasis has focused on reducing the impact of concomitant use of sedating medications (i.e. benzodiazepines) and other controlled substances (i.e. hypnotics, muscle relaxants) that synergistically increase risk of fatal overdose, especially in medically compromised individuals. Recent reports suggest that states with medical marijuana programs have lower rates of opioid overdose death. Possible mechanisms for lower rates of overdose include reductions in opioid use and/or the use of sedating medications due to symptomatic relief of comorbid anxiety or insomnia. However, little is known about the relationship between medical marijuana program participation among patients with pain conditions and changes in use patterns of controlled substance use. Even less is known about the differential impact of specific cannabinoid products medically dispensed (such as high tetrahydrocannabinol [THC] versus high cannabidiol [CBD] products). The New York State medical marijuana program (implemented January 2016) is one of the most highly regulated and medicalized programs in operation in the United States. State-licensed dispensaries must be staffed with licensed pharmacists and demonstrate that they dispense products with consistent cannabinoid ratios (including high-THC, high-CBD, and 1:1 THC:CBD products). New York State is therefore an ideal setting for a rigorous analysis of medical cannabis program participation and the impact of cannabinoid products with varying THC:CBD ratios on controlled substance use over time among chronic pain patients. We propose to partner with the largest medical marijuana provider in New York (> 10,000 participants enrolled as of October 2017). Participant activity is tracked through an electronic health record with de-identified patient characteristics at baseline (demographics, qualifying condition and symptoms, concomitant medications) that is linked to data containing 12-month controlled substance prescription history through the state’s prescription drug monitoring program (PDMP). The analysis of these de-identified, compiled records is a highly innovative and cost-effective method for better understanding the potential mechanisms of how participation in medical marijuana programs influences controlled substance use and overdose risk among patients with pain conditions receiving opioids and sedative-hypnotics and can inform subsequent prospective study designs.