Assessing the real-world impact of a low nicotine product standard for smoked tobacco in New Zealand

摘要 已提议为香烟和其他燃烧烟草产品制定低尼古丁产品标准，作为 美国食品和药物管理局烟草和尼古丁监管综合计划的基石。 这一拟议的标准主要基于随机临床试验，该试验表明，当人们转向 极低尼古丁含量(VLNC)香烟、每天吸烟、吸烟依赖和吸烟生物标志物 暴露减少，戒烟尝试增加，戒烟尝试增加。然而，这些试验有重要的局限性。 值得注意的是，它们限制了接触VLNC香烟的持续时间；不能重现REAL- 世界产品标准；其特点是使用未经研究的普通尼古丁香烟；以及一般 把重点放在方便的样品上。2021年12月，新西兰(新西兰)政府推出 无烟奥蒂亚罗亚2025年行动计划，概述了将吸烟率降低到5%以下的战略。这个 该计划是世界领先的，具有变革性的目标包括：1)消除吸烟率和 与吸烟有关的疾病；2)确保年轻人永远不开始吸烟；3)增加戒烟人数 烟。该倡议的一个主要组成部分是强制对所有吸烟的人实施较低的尼古丁产品标准。 烟草。我们的主要研究目标是评估强制减少尼古丁的现实影响 在所有吸烟烟草产品中通报美国在新西兰实施的尼古丁减少政策。我们建议 对每天或几乎每天吸烟的成年人(N=1500)进行纵向、混合方法的队列研究， 使用在线调查、暴露的生物标记物、生理评估、定性访谈和医学 评估吸烟行为、健康和幸福感变化的记录。我们将跟随这一队列3.5年 (低尼古丁产品标准实施前1.5年和实施后1年)。我们还将探索 通过从新西兰和新西兰重要的三个优先群体中明确抽样来实现潜在的异质性 美国(自称焦虑和抑郁的人；生活在社会经济贫困中的年轻人 地区；以及报告使用大量酒精和/或大麻的个人)，并确保新西兰族裔的代表性 吸烟流行率高得不成比例的群体(Māori，Pacifika)。我们还将招收以下人员 吸烟，但不属于优先人群。目标1的主要结果是戒烟 烟草(自我报告和生物化学验证)在政策实施后52周。初级阶段 AIM 2的结果是在政策实施52周后进行与健康相关的生活质量评级。目标3将 探索潜在的异质性，以应对低尼古丁产品标准。我们的建议将直接 告知拜登政府最近宣布的美国减少尼古丁政策议程，并与 RFA-OD-21-002中概述的几个优先事项。作为一个团队，我们有互补的专业领域(例如， 行为药理学、公共卫生和医学、生物统计学、流行病学、定性和混合 方法和卫生公平)，以确保圆满完成目前的提案。

ABSTRACT A low nicotine product standard for cigarettes and other combusted tobacco products has been proposed as a cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation in the United States (US). This proposed standard is based largely on randomized clinical trials demonstrating that when people switch to very low nicotine content (VLNC) cigarettes, cigarettes per day, dependence and biomarkers of smoke exposure decrease and quit attempts and cessation increase. Yet, these trials have impo rtant limitations. Notably, they limit the duration of exposure to VLNC cigarettes; cannot recreate the complex context of real - world product standards; are characterized by the use of non-study, normal nicotine cigarettes; and generally focus on samples of convenience. In December 2021, the New Zealand (NZ) Government launched the Smokefree Aotearoa 2025 Action Plan, outlining a strategy to reduce smoking prevalence to less than 5%. The plan is world-leading with transformative goals including: 1) eliminate health inequities in smoking rates and smoking-related illness; 2) ensure youth never start smoking tobacco; and 3) increase quitting in people who smoke. A major component of the initiative is to mandate a low nicotine product standard for all smoked tobacco. Our primary research objective is to assess the real-world impact of a mandated reduction of nicotine in all smoked tobacco products in NZ to inform the implementation of US nicotine reduction policy. We propose to conduct a longitudinal, mixed methods cohort study of adults who smoke daily or nearly daily (N=1500), using online surveys, biomarkers of exposure, physiological assessments, qualitative interviews, and medical records to assess changes in smoking behavior, health and well-being. We will follow the cohort for 3.5 years (1.5 years before and 1 year after implementation of a low nicotine product standard). We will also explore potential heterogeneity by explicitly sampling individuals from three priority populations important in NZ and the US (individuals with self-reported anxiety and depression; young adults living in socioeconomically deprived areas; and individuals who report heavy alcohol and/or cannabis use) and ensuring representation of NZ ethnic groups (Māori, Pacifika) with disproportionately high smoking prevalence. We will also enroll people who smoke but do not belong to priority populations. The primary outcome for Aim 1 is abstinence from smoked tobacco (self-reported and biochemically-verified) at 52 weeks after policy implementation. The primary outcome for Aim 2 is Health-Related Quality of Life ratings at 52 weeks after policy implementation. Aim 3 will explore potential heterogeneity in response to a low nicotine products standard. Our proposal will directly inform the US nicotine reduction policy agenda recently announced by the Biden Administration and aligns with several priorities outlined in RFA-OD-21-002. As a team, we have complementary areas of expertise (e.g., behavioral pharmacology, public health and medicine, biostatistics, epidemiology, qualitative and mixed methods, and health equity) to ensure the successful completion of the current proposal.