Enhancing FDA's opioids systems modeling efforts to more comprehensively address fentanyl, stimulants, polysubstance use, and associated outcomes

加强 FDA 的阿片类药物系统建模工作，以更全面地解决芬太尼、兴奋剂、多物质使用和相关结果

• 批准号: 10405847
• 负责人: Mohammad S. Jalali
• 金额: $ 124.92万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10405847
• 关键词: Enhancing; FDA; opioids; systems; modeling

PROJECT SUMMARY/ABSTRACT Overdoses involving stimulants like methamphetamine and cocaine, both alone and with fentanyl and its analogues (fentanyls), have risen rapidly in the last decade. Fentanyls have introduced elevated and unpredictable dangers through adulteration of illicit drug supplies, including stimulants, or through deliberate co-use with stimulants. The proposed research aims to expand the scope of FDA’s existing opioid system model (OSM) by adding detail regarding stimulant use, fentanyls adulteration of illicit stimulant supplies, and pill forms of fentanyls, as well as the effects of mental health disorders on developing opioid use disorder (OUD). We also propose to enhance FDA’s opioid systems modeling efforts by building a complementary model focusing on factors explaining the increase in co-use of, and overdoses involving, stimulants and opioids. The complementary model will be flexible and generalizable enough to apply to future drug crises and other geographies. The goal of the proposed research is to identify optimal intervention strategies to reduce nonfatal and fatal overdoses and improve quality of life. Our multidisciplinary team of substance use and simulation modeling experts will improve OSM estimates of quality of life and overdose rates, using a combination of national datasets (Aim 1.1), and will address an important gap in OSM by incorporating effects of mental health disorders on developing OUD (Aim 1.2). Via a qualitative research method used specifically in system dynamics, we will engage people who use drugs (PWUD) and experts on the subject to build a model complementary to OSM, which will include multi-level factors (e.g., mental health disorders, unpredictable potency of illicit drug supplies, PWUD risk mitigation strategies) that can explain the rise in co-use of opioids and stimulants and the rapid increases in overdoses involving stimulants (Aim 2.1). We will proactively design the model to be generalizable and easily updated based on geography and future drug use trends (Aim 2.2). The preceding Aims will allow further refinement of OSM estimates of the effects of intervention strategies on quality of life improvement and overdose reduction (Aim 3.1), while the complementary model will support testing additional intervention strategies for current and future crises (Aim 3.2). Together, these two models will enable the identification of intervention strategies that have the greatest possibility of reducing problematic use and deaths and improving quality of life, including generalizable strategies for future crises. The proposed research will provide insight to policymakers that can be readily applied to improve health outcomes by leveraging the best available information, including on-the-ground experiences of PWUD, to model the complex system involving intersecting crises of opioids, including fentanyls, and stimulants. Policy inferences from these models will inform national intervention strategy design that is optimized in terms of both fatal and nonfatal overdose reduction and quality of life improvement.

项目总结/摘要 涉及甲基苯丙胺和可卡因等兴奋剂的过量，无论是单独使用还是与芬太尼及其 类似物（芬太尼）在过去十年中迅速增加。芬太尼已经引入了升高和 非法药物供应，包括兴奋剂掺假，或故意 与兴奋剂合用。拟议的研究旨在扩大FDA现有阿片类药物系统的范围 模型（OSM），增加了关于兴奋剂使用，非法兴奋剂供应的芬太尼掺假的细节， 芬太尼的药丸形式，以及精神健康障碍对阿片类药物使用障碍的影响 （OUD）。我们还建议通过建立一个互补的模型来加强FDA的阿片类药物系统建模工作。 侧重于解释同时使用兴奋剂和涉及兴奋剂的药物过量增加的因素的模型， 阿片类药物补充模式将具有足够的灵活性和普遍性，可适用于未来的毒品危机， 其他地理。拟议研究的目标是确定最佳干预策略，以减少 非致命性和致命性过量，并改善生活质量。 我们的物质使用和模拟建模专家的多学科团队将提高OSM估计， 生活质量和过量使用率，使用国家数据集的组合（目标1.1），并将解决 通过纳入精神健康障碍对发展OUD的影响，在OSM中发现了一个重要的空白（目标1.2）。经由 系统动力学中专门使用的定性研究方法，我们将让使用药物的人参与其中 （PWUD）和专家就这一问题建立了一个模型，补充OSM，其中将包括多层次的 因素（例如，精神健康障碍、非法药物供应的不可预测效力、PWUD风险缓解 这可以解释阿片类药物和兴奋剂同时使用的增加以及过量使用的迅速增加 （目标2.1）。我们将积极设计模型，使其具有通用性和易于更新 基于地理位置和未来药物使用趋势（目标2.2）。上述目标将允许进一步完善 OSM估计干预策略对生活质量改善和过量减少的影响 (Aim 3.1），而补充模型将支持测试额外的干预战略， 未来的危机（目标3.2）。这两种模式结合起来，将有助于确定干预战略， 最有可能减少有问题的使用和死亡，并提高生活质量，包括 应对未来危机的普遍战略。 拟议中的研究将为政策制定者提供可随时用于改善健康的见解 通过利用现有最佳信息，包括PWUD的实地经验， 模拟涉及阿片类药物（包括芬太尼）和兴奋剂交叉危机的复杂系统。政策 从这些模型中得出的推论将为国家干预战略的设计提供信息， 致命性和非致命性过量减少和生活质量改善。