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.

尽管普通人群吸烟的吸烟显着减少，但吸烟率 经济不利的妇女有所增加。生殖年龄的妇女吸烟是 特别关心的是，因为除了通常的健康风险外，还有其他风险 孕。国家减少香烟的尼古丁政策具有减少烟草使用的巨大潜力， 依赖，并改善这些吸烟者的健康。一般人群样本中的对照试验具有 证明将吸烟者转为非常低的尼古丁含量香烟（VLNCCS）可以减少每次香烟 天（CPD），依赖性严重程度和烟草有毒物质暴露。我们在当前资金中的研究 期间表明，处境不利的妇女对vlnccs的反应，吸烟率降低，香烟 需求，依赖严重程度和其他成瘾措施。但是，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调节影响。期间 在下一个资金期间，我们将利用行为经济学和行为的原则和方法 实施时处境不利的妇女减少尼古丁政策的效果的药理学 单独或提供随时可用的替代品，未燃烧的尼古丁来源（电子烟）。到 模拟口味，电子烟的潜在影响，仅在烟草风味中检查或吸引人 个性化的口味。这项研究将是使用受试者间，四个平行组的多站点试验 务实的设计。处境不利的女性吸烟者（18 - 44年）将随机分为16周的：（1）正常 尼古丁含量香烟（NNCCS），控制条件； （2）单独使用VLNCC； （3）vlnccs +烟素化， 烟草味的电子烟（TF E-cigs）；或（4）vlnccs +烟碱化的优选味电子烟（PF E- CIGS）。结果指标包括CPD，产品需求，渴望，吸引力，有毒物质暴露，大脑功能， 和气道炎症。在第17周，参与者将进行节制评估，以测试是否是否 实验条件会影响戒烟的能力。该TCOR的综合主题是 脆弱的人群。拟议的研究与CTP成瘾的科学领域高度相关 和行为，因为它将测试减少香烟的尼古丁含量是否减少香烟的使用， 依赖性和产品吸引力，以及这些效果是否通过吸引力的可用性增强 非燃烧尼古丁的替代来源。它通过评估对 重要的生物标志物。这是重要的和创新的，因为它将模拟电子的可用性和吸引力 香烟可能会在一项经过研究的易受伤害的情况下降低国家减少纽约汀政策的有效性 人口。最后，这是有计划的，因为它将基于当前资金期间完成的工作 时期。总体而言，该提案有可能继续一项富有成效的多学科研究计划 这将为FDA提供与其监管责任有关的至关重要的证据。