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 已经提出了一种针对香烟和其他燃烧烟草产品的低尼古丁产品标准 美国FDA关于美国烟草和尼古丁法规的综合计划的基石（美国）。 该拟议的标准主要基于随机临床试验，表明当人们切换到 非常低的尼古丁含量（VLNC）香烟，每天香烟，依赖和生物标志物 暴露量减少，退出尝试和停止增加。然而，这些试验有局限性的局限性。 值得注意的是，它们限制了接触VLNC香烟的持续时间。无法重现真实的复杂环境 - 世界产品标准；其特征是使用非研究，正常的尼古丁香烟。通常 专注于方便样本。 2021年12月，新西兰（新西兰）政府启动了 无烟Aotearoa 2025行动计划，概述了将吸烟流行率降低到5％的策略。这 计划具有变革性目标，包括：1）消除吸烟率和 与吸烟有关的疾病； 2）确保青年永远不会开始吸烟； 3）使那些安静的人安静 抽烟。该计划的主要组成部分是要求所有烟熏的尼古丁产品标准 烟草。我们的主要研究目标是评估尼古丁的强制性减少的现实影响 在新西兰的所有烟熏烟草产品中，以告知美国减少尼古丁政策的实施。我们建议 进行每天或几乎每天吸烟的成年人的纵向，混合方法队列研究（n = 1500）， 使用在线调查，曝光的生物标志物，物理评估，定性访谈和医学 记录以评估吸烟行为，健康和福祉的变化。我们将遵循3。5年 （在实施低尼古丁产品标准后1年和1年之前）。我们还将探索 潜在的异质性是通过对新西兰重要的三个优先人群的明确采样个人进行的， 我们（有自我报告的动画和抑郁的人；生活在社会经济上的年轻人 区域；以及报告大量酒精和/或大麻的人）并确保代表新西兰民族 群（毛利人，太平洋地区）的吸烟率高。我们还将注册谁 烟，但不属于优先人群。目标1的主要结果是戒烟 实施政策后52周，烟草（自我报告和生化验证）。主要 AIM 2的结果是政策实施后52周与健康相关的生活质量评级。目标3意志 探索潜在的异质性，以响应低尼古丁产品标准。我们的建议将直接 告知拜登政府最近宣布的美国尼古丁减少政策议程，并与 RFA-OD-21-002中概述了几个优先事项。作为一个团队，我们拥有完整的专业领域（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 方法和健康平等），以确保成功完成当前建议。