Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

情感障碍(ADS；情绪和焦虑障碍)是老年人最常见的心理健康状况 我们。超过40%的广告人是目前的吸烟者，他们经历了不成比例的高吸烟率 烟草相关疾病和死亡。一项针对香烟的国家尼古丁减少政策有可能减少 烟草依赖和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)会减少 每天吸烟(CPD)、香烟依赖和烟草毒物暴露，几乎没有不良反应 后果。此外，我们在当前资助期的工作表明，带有广告的吸烟者对 减少卷烟需求和其他成瘾措施的VLNCC。然而，烟草市场 条件可能会对香烟减少尼古丁政策的有效性产生相当大的影响。 在下一个资助期，我们将运用行为经济学和行为经济学的原理和方法 检查VLNCC对吸烟者使用ADS的影响的药理学，无论是单独使用还是同时提供替代药物 非燃烧来源的尼古丁(电子烟)。在不同的条件下，电子烟将在烟草中提供 仅限口味或以吸引人的个性化口味。本次多点试验采用四组平行、务实的设计。 每天有广告的吸烟者将被随机分为16周：(1)单独服用正常尼古丁含量香烟(NNCC)， 控制条件，(2)单独的VLNCCs，(3)VLNCCs+烟化的烟草味(Tf e-cigs)，或(4)VLNCCs +烟化、偏爱口味的电子烟(PF e-cigs)。结果指标包括CPD、产品需求、渴望、 上诉，精神症状，脑功能的生物标记物，烟草毒物暴露和 呼吸道发炎。在使用16周后，参与者将接受禁欲评估，在评估中，我们 检查研究条件对参与者戒烟能力及其反应的影响 为了禁欲。这一TCORS的综合主题是弱势群体。拟议中的研究具有很高的 与CTP的成瘾和行为的科学领域相关，因为它将检查是否减少 香烟中的尼古丁含量减少了香烟的使用、依赖和产品吸引力，以及这些影响是否 电子烟的普及加强了这一趋势。它将通过评估 这些情况对脑功能、烟草毒物暴露和呼吸道炎症的生物标志物的影响。 拟议的研究具有重大意义和创新性，因为它将模拟电子烟的可用性和吸引力 在一个未被研究的国家香烟减少尼古丁政策的有效性可能会有所缓和 人口。最后，它是纲领性的，因为它将建立在我们在本年度完成的工作的基础上。 资助期。总体而言，这项提议有可能继续进行富有成效的多学科研究 计划，并将向FDA提供与其监管相关的至关重要的经验证据 责任。

Affective disorders (ADs; mood and anxiety disorders) are the most common mental health conditions in the US. Over 40% of people with ADs are current smokers, and they experience disproportionately high rates of tobacco-related disease and death. A national nicotine reduction policy for cigarettes has the potential to reduce tobacco 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) results in reductions in cigarettes per day (CPD), cigarette dependence, and tobacco toxicant exposure, with few adverse consequences. Furthermore, our work during the current funding period indicates that smokers with ADs respond to VLNCCs with reductions in cigarette demand and other measures of addiction. However, tobacco market conditions are likely to exert considerable influence over the effectiveness of a cigarette nicotine reduction policy. During the next funding period, we will utilize principles and methods of behavioral economics and behavioral pharmacology to examine the effects of VLNCCs in smokers with ADs, either alone or while providing a substitute non-combusted source of nicotine (e-cigarettes). In separate conditions, e-cigarettes will be provided in tobacco flavors only or in appealing personalized flavors. This multi-site trial uses a four parallel group, pragmatic design. Daily smokers with ADs 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 (TF e-cigs), or (4) VLNCCs + nicotinized, preferred-flavored e-cigs (PF e-cigs). Outcome measures include CPD, product demand, craving, appeal, psychiatric symptoms, biomarkers of brain function, and biomarkers of tobacco toxicant exposure and airway inflammation. After 16 weeks of use, participants will undergo an abstinence assessment in which we examine the effects of the study conditions on participants’ ability to abstain from cigarettes and their responses to abstinence. 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 examine whether reducing the nicotine content of cigarettes reduces cigarette use, dependence, and product appeal, and whether these effects are enhanced by the availability of e-cigarettes. It will address the Health Effects domain by assessing the effects of these conditions on biomarkers of brain function, tobacco toxicant exposure, and airway inflammation. The proposed study is significant and innovative because it will model how availability and appeal of e-cigs may moderate the effectiveness of a national reduced-nicotine policy for cigarettes in an understudied population. Finally, it is programmatic, as it will build upon the work that we accomplished during the current funding period. Overall, this proposal has the potential to continue a highly productive multidisciplinary research program and will provide FDA with critically important empirical evidence relevant to its regulatory responsibilities.