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
基本信息
- 批准号:10665851
- 负责人:
- 金额:$ 72.02万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AbstinenceAddressAdministrative SupplementAdultAgeAlcohol consumptionAreaAuthorization documentationBehaviorBiochemicalBiological MarkersBiometryBody mass indexCardiovascular PhysiologyCigaretteCohort StudiesComplexDataDependenceEnrollmentEnsureEpidemiologyEthnic PopulationEvaluationExposure toFeelingGenderGoalsGovernmentHealthHeavy DrinkingHeterogeneityHomeIndigenousIndividualIndividual DifferencesInternationalInterviewLeadMedical RecordsMedicineMental DepressionMental HealthMethodsNew ZealandNicotineOutcomePatient Self-ReportPerceptionPersonal SatisfactionPersonsPhysiologicalPoliciesPopulationPsyche structurePublic HealthRegulationReportingResearchResearch PersonnelSamplingSmokeSmokingSmoking BehaviorSubgroupSurveysTimeTobaccoTobacco smokeTobacco useUnited StatesWeightYouthauthoritybehavioral outcomebehavioral pharmacologycohorteconomic disparityhealth assessmenthealth disparityhealth equityhealth inequalitieshealth related quality of lifeimprovedlow nicotine content cigarettemarijuana usenicotine usephysical conditioningprimary outcomepulmonary functionrandomized, clinical trialsrecruitresponseself-reported anxietysmoking prevalencesocialsocioeconomicstobacco productsyoung adult
项目摘要
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.
摘要
已提议对香烟和其他燃烧的烟草产品实行低尼古丁产品标准,
这是FDA在美国(US)制定的烟草和尼古丁监管综合计划的基石。
这一标准的提出主要是基于随机临床试验,这些试验表明,当人们转向
极低尼古丁含量(VLNC)香烟,每日吸烟量,吸烟的依赖性和生物标志物
接触减少,戒烟尝试和戒烟增加。然而,这些试验具有重要的局限性。
值得注意的是,它们限制了暴露于VLNC香烟的持续时间;不能重现真实的的复杂背景-
世界产品标准;以使用非研究、正常尼古丁香烟为特征;一般
专注于方便的样品。2021年12月,新西兰政府推出了
《无烟奥特亚罗瓦2025行动计划》概述了将吸烟率降至5%以下的战略。的
该计划是世界领先的,其变革性目标包括:1)消除吸烟率方面的健康不平等,
吸烟相关疾病; 2)确保年轻人永远不会开始吸烟; 3)增加吸烟者的戒烟率,
抽烟该倡议的一个主要组成部分是强制所有吸烟者使用低尼古丁产品标准。
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
在新西兰的所有吸烟烟草产品中,为美国尼古丁减少政策的实施提供信息。我们提出
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,暴露的生物标志物,生理评估,定性访谈和医疗
记录来评估吸烟行为、健康和福祉的变化。我们将对该队列进行为期3.5年的跟踪研究
(1.5实施低尼古丁产品标准前1年和实施低尼古丁产品标准后1年)。我们还将探索
潜在的异质性,明确抽样个人从三个重要的优先群体在新西兰和
美国(自我报告焦虑和抑郁的个人;生活在社会经济贫困地区的年轻人)
以及报告酗酒和/或吸食大麻的个人),并确保新西兰族裔
吸烟率高得不成比例的群体(毛利人、非裔毛利人)。我们还将招收
吸烟,但不属于优先人群。目标1的主要结局是戒烟
烟草(自我报告和生物化学验证)在政策实施后52周。主
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。目标3将
探索响应低尼古丁产品标准的潜在异质性。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
方法和卫生公平),以确保圆满完成目前的提案。
项目成果
期刊论文数量(0)
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会议论文数量(0)
专利数量(0)
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ERIC Christian DONNY其他文献
ERIC Christian DONNY的其他文献
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{{ truncateString('ERIC Christian DONNY', 18)}}的其他基金
MARVEL: A Multidisciplinary Assessment of Risks from Vaping during Early Life
MARVEL:对生命早期电子烟风险的多学科评估
- 批准号:
10628250 - 财政年份:2023
- 资助金额:
$ 72.02万 - 项目类别:
Project 1 - Vaping Behavior, the Emergence of Dependence, and Well-being
项目 1 - 电子烟行为、依赖性的出现和幸福感
- 批准号:
10628251 - 财政年份:2023
- 资助金额:
$ 72.02万 - 项目类别:
EFFECTS OF NICOTINE YIELD & NICOTINE REPLACEMENT ON VERY LOW NICOTINE CONTENT CIG
尼古丁产量的影响
- 批准号:
8153483 - 财政年份:2011
- 资助金额:
$ 72.02万 - 项目类别:
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