Low Nicotine Content Cigarettes in Vulnerable Populations: Economically Disadvantaged Women (Non-Pregnant)

弱势群体中的低尼古丁含量香烟：经济弱势妇女（非怀孕）

• 批准号: 10477405
• 负责人: Stephen T Higgins
• 金额: $ 52.86万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477405
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Abstinence; Address; Adult; Affect; Age; Behavior; Biological Markers; Brain; Carbon Monoxide; Cerebrovascular Circulation; Cigarette; Dependence; Economically Deprived Population; Effectiveness; Electronic cigarette; Exhalation; Experimental Models; Female; Flavoring; Funding; General Population; Goals; Health; Laboratories; Malignant neoplasm of cervix uteri; Measures; Methods; Modeling; Nicotine; Nicotine Dependence; Nitric Oxide; Outcome; Outcome Measure; Participant; Policies; Population; Prevalence; Randomized; Reproductive Health; Research; Risk; Sampling; Science; Secondary to; Severities; Smoke; Smoker; Smoking; Source; Structure; Testing; Tobacco; Tobacco Dependence; Tobacco-Associated Carcinogen; Toxicant exposure; Toxin; Universities; Vermont; Visit; Vulnerable Populations; Withdrawal; Woman; Work; addiction; addiction liability; airway inflammation; behavioral economics; behavioral pharmacology; cigarette smoking; craving; design; disadvantaged women; financial incentive; improved; innovation; low nicotine content cigarette; multi-site trial; multidisciplinary; pregnant; programs; reduce tobacco use; reproductive; smoking addiction; smoking prevalence; socioeconomic disadvantage; tobacco flavor; tobacco toxicant

Despite marked reductions in cigarette smoking in the general population, smoking rates among economically disadvantaged women have increased. Smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. A national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in these smokers. Controlled trials in general population samples have demonstrated that switching smokers to very low nicotine content cigarettes (VLNCCs) reduces cigarettes per day (CPD), dependence severity, and tobacco toxicant exposure. Our research during the current funding period indicates that disadvantaged women respond to VLNCCs with reductions in smoking rates, cigarette demand, dependence severity, and other measures of addiction. However, tobacco market conditions are likely to exert a considerable moderating influence over the effectiveness of a nicotine reduction policy. During the next funding period, we will utilize principles and methods of behavioral economics and behavioral pharmacology to model effects of a reduced nicotine policy among disadvantaged women when implemented alone or while providing a readily available substitute, non-combusted source of nicotine (e-cigarettes). To model the potential influence of flavors, e-cigarettes will be examined in tobacco flavors only or appealing personalized flavors. This study will be a multi-site trial using a between-subject, four parallel groups, pragmatic design. Disadvantaged female smokers (18-44 yrs) will be randomized to 16 weeks of: (1) normal nicotine content cigarettes (NNCCs) alone, the control condition; (2) VLNCCs alone; (3) VLNCCs + nicotinized, tobacco-flavored e-cigarettes (TF e-cigs); or (4) VLNCCs + nicotinized, preferred-flavor e-cigarettes (PF e- cigs). Outcome measures include CPD, product demand, craving, appeal, toxicant exposure, brain function, and airway inflammation. In Week 17, participants will undergo an abstinence assessment to test whether the experimental conditions affect the ability to abstain from cigarettes. The integrative theme of this TCORS is vulnerable populations. The proposed research is highly relevant to CTP's scientific domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces cigarette use, dependence, and product appeal, and whether these effects are enhanced by the availability of an appealing alternative source of non-combusted nicotine. It addresses the Health Effects domain by assessing effects on important biomarkers. It is significant and innovative because it will model how availability and appeal of e- cigarettes may moderate the effectiveness of a national reduced-nicotine policy in an understudied, vulnerable population. Finally, it is programmatic as it will build upon work accomplished during the current funding period. Overall, this proposal has the potential to continue a productive, multidisciplinary program of research that will provide FDA with critically important evidence relevant to its regulatory responsibilities.

尽管普通人群中吸烟的人数明显减少，但 经济上处于不利地位的妇女有所增加。在育龄妇女中吸烟是一种 特别令人担忧的是，除了通常的健康风险外，如果它们成为 怀孕了。国家减少香烟尼古丁的政策在减少烟草使用方面有相当大的潜力， 依赖，并改善这些吸烟者的健康。在普通人群样本中进行的对照试验 证明将吸烟者改用尼古丁含量极低的香烟(VLNCC)可减少 天数(CPD)、依赖严重程度和烟草毒物暴露。我们的研究在目前的资金支持下 时期表明，处于不利地位的妇女对VLNCC的反应是吸烟率降低，吸烟 需求、依赖严重程度和其他成瘾指标。然而，烟草市场状况是 可能对减少尼古丁政策的有效性产生相当大的缓和影响。在.期间 在下一个资助期，我们将利用行为经济学和行为经济学的原理和方法 实施减少尼古丁政策对弱势妇女影响的药理学模型 单独或同时提供一种现成的、非燃烧的尼古丁替代来源(电子烟)。至 模拟味道的潜在影响，电子烟将仅在烟草味道或吸引力方面进行检查 个性化的口味。这项研究将是一项多点试验，采用受试者之间、四个平行小组、 实用的设计。弱势女性吸烟者(18-44岁)将被随机分配到16周内：(1)正常 尼古丁含量香烟(NNCCs)单独，对照条件；(2)VLNCCs单独；(3)VLNCCs+烟化， 烟草味电子烟(TF e-cigs)；或(4)VLNCCs+烟化、偏爱香型电子烟(PF e-cigs) 香烟)。结果测量包括CPD，产品需求，渴望，吸引力，毒物暴露，脑功能， 和呼吸道炎症。在第17周，参与者将接受禁欲评估，以测试 实验条件会影响戒烟的能力。这次TCORS的综合主题是 弱势群体。这项拟议的研究与CTP的成瘾科学领域高度相关 和行为，因为它将测试减少香烟中的尼古丁含量是否会减少香烟的使用， 依赖性和产品吸引力，以及这些影响是否因提供有吸引力的产品而增强 非燃烧尼古丁的替代来源。它通过评估对以下方面的影响来解决健康影响领域 重要的生物标志物。它具有重大意义和创新性，因为它将模拟电子产品的可用性和吸引力- 香烟可能会削弱国家减少尼古丁政策在未被研究、易受伤害的人中的有效性 人口。最后，它具有纲领性，因为它将建立在当前供资期间完成的工作的基础上 句号。总体而言，这项提议有可能继续进行富有成效的、多学科的研究计划 这将为FDA提供与其监管责任相关的至关重要的证据。