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

尽管普通人群的吸烟率明显下降， 经济上处于不利地位的妇女有所增加。育龄妇女吸烟是一种 特别值得关注的是，除了通常的健康风险外，如果他们成为 怀孕了一项全国性的香烟尼古丁减少政策在减少烟草使用方面具有相当大的潜力， 并改善这些吸烟者的健康状况。一般人群样本的对照试验 研究表明，吸烟者改用尼古丁含量极低的香烟（VLNCC）， 日（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 这一时期表明，弱势妇女对VLNCC的反应是吸烟率降低， 需求，依赖严重程度和其他成瘾措施。然而，烟草市场的情况 可能会对尼古丁减少政策的有效性产生相当大的缓和影响。期间 在下一个融资期，我们将利用行为经济学和行为经济学的原理和方法， 药理学，以模拟实施减少尼古丁政策对弱势妇女的影响 单独使用或同时提供容易获得的替代品，尼古丁的非燃烧来源（电子烟）。到 模型的潜在影响的口味，电子烟将在烟草口味只或有吸引力的审查 个性化口味本研究将是一项多中心试验，采用受试者间、4个平行组， 务实的设计不稳定的女性吸烟者（18-44岁）将被随机分配至16周：（1）正常 单独的尼古丁含量香烟（NNCC），对照条件;（2）单独的VLNCC;（3）VLNCC+尼古丁， 烟草味电子烟（TF电子烟）;或（4）VLNCC+尼古丁化的优选口味电子烟（PF电子烟）。 香烟）。结果指标包括CPD，产品需求，渴望，吸引力，毒物暴露，脑功能， 和气道炎症。在第17周，参与者将接受禁欲评估，以测试 实验条件影响戒烟的能力。本TCORS的综合主题是 弱势群体。这项研究与CTP的成瘾科学领域高度相关 和行为，因为它将测试是否减少香烟的尼古丁含量减少香烟的使用， 依赖性和产品吸引力，以及这些影响是否因吸引力的可用性而增强 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。它是重要的和创新的，因为它将模型如何可用性和吸引力的电子- 香烟可能会缓和国家减少尼古丁政策的有效性， 人口最后，它是方案性的，因为它将在当前供资期间完成的工作的基础上更进一步 期总的来说，这项建议有可能继续进行富有成效的多学科研究计划。 这将为FDA提供与其监管职责相关的至关重要的证据。

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.