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

评估新西兰低尼古丁产品标准对吸食烟草的现实影响

• 批准号: 10665851
• 负责人: ERIC Christian DONNY
• 金额: $ 72.02万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665851
• 关键词: Abstinence; Address; Administrative Supplement; Adult; Age; Alcohol consumption; Area; Authorization documentation; Behavior; Biochemical; Biological Markers; Biometry; Body mass index; Cardiovascular Physiology; Cigarette; Cohort Studies; Complex; Data; Dependence; Enrollment; Ensure; Epidemiology; Ethnic Population; Evaluation; Exposure to; Feeling; Gender; Goals; Government; Health; Heavy Drinking; Heterogeneity; Home; Indigenous; Individual; Individual Differences; International; Interview; Lead; Medical Records; Medicine; Mental Depression; Mental Health; Methods; New Zealand; Nicotine; Outcome; Patient Self-Report; Perception; Personal Satisfaction; Persons; Physiological; Policies; Population; Psyche structure; Public Health; Regulation; Reporting; Research; Research Personnel; Sampling; Smoke; Smoking; Smoking Behavior; Subgroup; Surveys; Time; Tobacco; Tobacco smoke; Tobacco use; United States; Weight; Youth; authority; behavioral outcome; behavioral pharmacology; cohort; economic disparity; health assessment; health disparity; health equity; health inequalities; health related quality of life; improved; low nicotine content cigarette; marijuana use; nicotine use; physical conditioning; primary outcome; pulmonary function; randomized, clinical trials; recruit; response; self-reported anxiety; smoking prevalence; social; socioeconomics; tobacco products; young adult

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.

抽象的 已提出针对卷烟和其他燃烧烟草产品的低尼古丁产品标准 FDA 美国 (US) 烟草和尼古丁监管综合计划的基石。 该提议的标准主要基于随机临床试验，证明当人们转向 极低尼古丁含量 (VLNC) 香烟、每天香烟、依赖性和烟雾生物标志物 然而，这些试验有很大的局限性。 值得注意的是，它们限制了接触 VLNC 香烟的时间，无法重现真实的复杂环境—— 世界产品标准；其特点是使用非学习型普通尼古丁香烟； 2021 年 12 月，新西兰 (NZ) 政府推出了注重便利性的样品。 无烟新西兰 2025 年行动计划，概述了将吸烟率降至 5% 以下的战略。 该计划处于世界领先地位，其变革性目标包括：1）消除吸烟率和健康方面的不平等现象 与吸烟相关的疾病；2) 确保青少年永远不会开始吸烟；以及 3) 增加吸烟者的戒烟率； 该倡议的一个主要组成部分是为所有吸烟者强制执行低尼古丁产品标准。 我们的主要研究目标是评估强制减少尼古丁的现实世界影响。 我们建议在新西兰所有吸烟产品中通报美国尼古丁减少政策的实施。 对每天或几乎每天吸烟的成年人 (N=1500) 进行纵向、混合方法队列研究， 使用在线调查、暴露生物标志物、生理评估、定性访谈和医学 我们将跟踪该队列 3.5 年，以评估吸烟行为、健康和福祉的变化。 （低尼古丁产品标准实施前1.5年和实施后1年我们也会探讨）。 通过从新西兰和新西兰重要的三个优先人群中明确抽样个体来确定潜在的异质性 美国（自我报告患有焦虑和抑郁的个人；生活在社会经济贫困中的年轻人 地区；以及报告酗酒和/或吸食大麻的个人）并确保新西兰族裔的代表性 我们还将招募吸烟率极高的群体（毛利人、太平洋岛民）。 吸烟但不属于优先人群 目标 1 的主要成果是戒烟。 政策实施后 52 周的烟草（自我报告和生化验证）。 目标 2 的结果是政策实施后 52 周的健康相关生活质量评级。 我们的提案将直接探索应对低尼古丁产品标准的潜在异质性。 通报拜登政府最近宣布的美国尼古丁减少政策议程，并与 RFA-OD-21-002 中概述的几个优先事项 作为一个团队，我们拥有互补的专业领域（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 方法和健康公平），以确保当前提案的成功完成。