Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

情感障碍（AD;情绪和焦虑障碍）是美国最常见的心理健康状况。 我们超过40%的AD患者目前是吸烟者，他们的吸烟率不成比例地高。 烟草相关疾病和死亡。一项全国性的香烟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。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）会导致 每天吸烟量（CPD）、香烟依赖和烟草毒物暴露， 后果此外，我们在当前资助期间的工作表明，患有AD的吸烟者 通过减少香烟需求和其他成瘾措施，向VLNCC提供服务。烟草市场 情况可能会对香烟尼古丁减少政策的有效性产生相当大的影响。 在下一个资助期内，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，以检查VLNCC在AD吸烟者中的作用，无论是单独使用还是同时提供替代品 尼古丁的非燃烧来源（电子烟）。在单独的条件下，电子烟将提供烟草 或者以吸引人的个性化口味。本次多点试验采用了四个平行组，务实设计。 患有AD的每日吸烟者将被随机分配至16周的：（1）单独的正常尼古丁含量香烟（NNCC）， 对照条件，（2）单独的VLNCC，（3）VLNCC+尼古丁化的烟草味（TF电子烟），或（4）VLNCC + 尼古丁化的，偏好口味的电子烟（PF电子烟）。结果指标包括CPD、产品需求、渴望、 上诉，精神症状，脑功能的生物标志物，以及烟草毒物暴露的生物标志物， 气道炎症使用16周后，参与者将接受禁欲评估， 检查研究条件对参与者戒烟能力及其反应的影响 禁欲这一TCORS的综合主题是弱势群体。该研究建议高度 与CTP的成瘾和行为的科学领域有关，因为它将研究是否减少 香烟中的尼古丁含量降低了香烟的使用，依赖性和产品吸引力，以及这些影响是否 电子烟的普及让这一趋势更加明显。它将通过评估健康影响领域， 这些条件对脑功能、烟草毒物暴露和气道炎症的生物标志物的影响。 拟议的研究是重要的和创新的，因为它将模拟如何可用性和吸引力的电子烟 在一个未充分研究的国家， 人口最后，它是方案性的，因为它将建立在我们在本报告所述期间完成的工作的基础上。 融资期。总的来说，这一建议有可能继续进行富有成效的多学科研究。 计划，并将为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.