Evaluationg the effects of e-cigarettes vs. oral nicotine pouches and product constituents (menthol flavor, nicotine concentration) on adult cigarette smoking and addiction

项目4摘要 吸烟仍然是可预防的疾病和死亡的主要原因。因此，更好地以人口为基础 迫切需要制定战略，减少吸烟和与烟草有关的危害。一种方法是 改善对香烟和其他烟草产品的监管，这是美国食品和药物管理局的核心使命 根据《烟草控制法案》，美国药品监督管理局(FDA)。事实上，FDA已经发出信号，表示它打算禁止 香烟中的薄荷醇和较低的尼古丁浓度，以保护公众健康。FDA可能会考虑类似的 限制味道和降低不可燃产品中尼古丁浓度的产品标准。 然而，需要科学数据来理解这些规定的影响。例如，FDA有 到目前为止，只批准烟草味的电子烟上市，尼古丁含量高和中等 浓度，并仍在评估上市前薄荷醇不可燃烟草产品的应用 产品。虽然电子烟和电子烟袋可以帮助成年人减少吸烟和吸烟相关的危害，但它 薄荷脑的味道和较高的尼古丁浓度是否在非可燃物质中仍有待确定 产品对于成年人的香烟替代品是很重要的。向烟草监管政策通报电子烟和 袋，我们建议对非可能燃烧烟草产品的影响进行对照试验 成人吸烟行为的类型和成分。具体地说，我们将随机选择目前 抽香烟(N=256)以切换到电子烟或袋子，为期4周，并将随机分配 参与者参与了产品中四种可能的监管方案，其中口味可用为薄荷醇和 仅限烟草/无香料或烟草/无香料，且尼古丁浓度高(5%电子烟或6毫克 眼袋)或中度(2.4%电子烟或3毫克眼袋)。设计将产生8个条件(N=32个参与者)。 来自这些参与者的数据将被用来比较产品类型、风味可获得性和尼古丁的影响 使用有效的自我报告措施和方法集中于吸烟行为和依赖 生物标志物(目标1)，并评估这些条件对电子烟/邮袋使用行为和吸引力的影响 使用有效的自我报告措施和生物标记物(目标2)。此外，我们还将探索潜在的相互作用 在条件(例如，味道可获得性和尼古丁浓度)和参与者特征(性别、 种族/民族、薄荷醇香烟偏好和基线尼古丁依赖程度)(目标3)。我们的分析 将提供关于哪些人更有可能完全从吸烟转向不吸烟的关键信息 可燃产品以及这些产品中的某些味道或尼古丁浓度是否对 成年人中香烟的替代性和吸引力。该项目重点关注FDA行为的关键优先领域， 上瘾和影响分析。我们的研究结果将为FDA提供有关非可燃物质的重要证据 香精和尼古丁的产品标准，以最大限度地提高其对吸烟和烟草的潜在益处 减少危害。

PROJECT 4 ABSTRACT Cigarette smoking remains the leading cause of preventable disease and death. Thus, better population-based strategies are urgently needed to reduce cigarette smoking and tobacco-related harm. One approach is to improve regulation of cigarettes and other tobacco products, which is a core mission of the U.S. Food and Drug Administration (FDA) under the Tobacco Control Act. Indeed, the FDA has signaled its intention to ban menthol and lower nicotine concentrations in cigarettes to protect public health. The FDA may consider similar product standards that restrict flavors and lower nicotine concentrations in non-combustible products as well. However, scientific data is needed to understand the impact of these regulations. For example, the FDA has approved only tobacco flavored e-cigarettes for marketing so far, in both high and moderate nicotine concentrations, and is still evaluating premarket tobacco product applications for menthol non-combustible products. Although e-cigarettes and pouches may help adults reduce smoking and smoking-related harm, it remains to be determined whether menthol flavor and higher nicotine concentrations in non-combustible products are important for cigarette substitution in adults. To inform tobacco regulatory policies of e-cigs and pouches, we propose to conduct a controlled trial of the effects of non-combustible tobacco product type and constituents on smoking behaviors in adults. Specifically, we will randomize adults who currently smoke cigarettes (N=256) to switch to either e-cigs or pouches for 4-weeks and will also randomly assign participants to four possible regulatory scenarios within product where flavor availability is either menthol and tobacco/unflavored or tobacco/unflavored only, and nicotine concentration is either high (5% e-cig or 6mg pouch) or moderate (2.4% e-cig or 3mg pouch). The design will yield 8 conditions (N=32 participants each). Data from these participants will be used to compare the effects of product type, flavor availability, and nicotine concentration on cigarette smoking behaviors and dependence using validated self-report measures and biomarkers (Aim 1), and to assess the effects of these conditions on e-cig/pouch use behaviors and appeal using validated self-report measures and biomarkers (Aim 2). In addition, we will explore potential interactions between conditions (e.g., flavor availability and nicotine concentration) and participant characteristics (sex, race/ethnicity, menthol cigarette preference, and baseline nicotine dependence level) (Aim 3). Our analyses will provide key information on which individuals may be more likely to switch completely from smoking to non- combustible products and whether certain flavors or nicotine concentrations in these products are important for cigarette substitution and appeal among adults. This project focuses on key FDA priority areas of behavior, addiction, and impact analysis. Our results will provide crucial evidence to the FDA about non-combustible product standards for flavor and nicotine to maximize their potential benefit on cigarette smoking and tobacco harm reduction.