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

评估电子烟与口服尼古丁袋和产品成分（薄荷醇风味、尼古丁浓度）对成人吸烟和成瘾的影响

• 批准号: 10666238
• 负责人: LISA M FUCITO
• 金额: $ 34.1万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666238
• 关键词: Address; Adult; Area; Authorization documentation; Behavior; Biological Markers; Carbon Monoxide; Cessation of life; Characteristics; Cigarette; Clinical Trials; Data; Dependence; Disease; Electronic cigarette; Ethnic Origin; Formulation; Harm Reduction; Individual; Intention; Interview; Lead; Marketing; Measures; Menthol; Mission; Modeling; Morbidity - disease rate; Nicotine; Nicotine Dependence; Oral; Participant; Patient Self-Report; Policies; Public Health; Race; Randomized; Randomized, Controlled Trials; Regulation; Sex Differences; Signal Transduction; Smoke; Smoking; Smoking Behavior; Sodium Chloride; Testing; Tobacco; Tobacco use; United States Food and Drug Administration; addiction; authority; cigarette addiction; cigarette smoke; cigarette smoking; combustible tobacco; design; electronic cigarette use; improved; mortality; nicotine exposure; population based; preference; primary outcome; public health priorities; secondary outcome; sex; smoking addiction; smoking cessation; tobacco advertising; tobacco control; tobacco flavor; tobacco products; tobacco regulatory science; willingness

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.

项目4摘要 吸烟仍然是可预防疾病和死亡的主要原因。因此，更好地基于人口 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制品的监管，这是美国食品和药物管理局的核心使命， 根据《烟草控制法》，美国药品管理局（FDA）。事实上，FDA已经表示打算禁止 薄荷醇和降低香烟中的尼古丁浓度，以保护公众健康。FDA可能会考虑类似的 产品标准，限制口味和降低尼古丁浓度的不可燃产品以及。 然而，需要科学数据来了解这些法规的影响。例如，FDA已 到目前为止，只有烟草味的电子烟被批准上市，无论是高尼古丁还是中等尼古丁。 浓度，并仍在评估薄荷醇不可燃的上市前烟草产品应用 产品.虽然电子烟和烟袋可能有助于成年人减少吸烟和吸烟相关的危害， 仍有待确定的是，薄荷醇香料和较高的尼古丁浓度， 产品对成人来说是香烟替代品。告知电子烟的烟草监管政策， 袋，我们建议进行对照试验的影响，不可燃烟草产品 吸烟类型及构成因素对成年人吸烟行为的影响。具体来说，我们将随机选择目前 吸烟者（N=256）转换为电子烟或袋4周，并将随机分配 参与者在产品中的四种可能的监管方案，其中香料可用性是薄荷醇， 烟草/未调味或仅烟草/未调味，并且尼古丁浓度高（5%电子烟或6 mg 袋）或中度（2.4%电子烟或3 mg袋）。该设计将产生8个条件（每个条件N=32名参与者）。 来自这些参与者的数据将用于比较产品类型、风味可用性和尼古丁的影响 使用经验证的自我报告措施， 生物标志物（目标1），并评估这些条件对电子烟/袋使用行为和吸引力的影响 使用经过验证的自我报告措施和生物标志物（目标2）。此外，我们还将探索潜在的相互作用 在条件之间（例如，香料可用性和尼古丁浓度）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水平）（目标3）。我们的分析 将提供关键信息，说明哪些人更有可能完全从吸烟转向不吸烟。 可燃产品，以及这些产品中的某些香料或尼古丁浓度是否对 香烟替代品和成人的吸引力。该项目侧重于FDA的关键优先行为领域， 成瘾和影响分析。我们的研究结果将为FDA提供关于不可燃的关键证据。 香料和尼古丁的产品标准，以最大限度地发挥其对吸烟和烟草的潜在好处 减少伤害。