Behavioral and Neural Response to Reduced Nicotine Cigarettes in Young Smokers

描述：《家庭吸烟预防和烟草控制法案》为FDA提供了一个独特的机会来影响公共健康的巨大改善。美国食品和药物管理局被授予监管烟草产品中主要成瘾剂尼古丁水平的权力，它有权帮助解决烟草吸烟问题。在美国，吸烟是可预防的死亡和疾病的主要贡献者，每年有40万人死亡。尽管以前在降低全国吸烟率方面取得了成功，但烟草吸烟率已稳定在成年人口的19%左右。更令人担忧的是，年轻人(18-25岁)是美国吸烟率最高的年龄段，为34%。为了让FDA实现其宣称的优先事项“减少对烟草产品的依赖”，有一些关键的科学问题必须得到回答。具体地说，FDA必须提供必要的数据，以确定(1)香烟中尼古丁的最佳产量水平，以 减少吸烟和烟草依赖，同时仍然缓解尼古丁渴望和戒烟，以及(2)减少不同尼古丁产量将如何影响大量吸烟者，并可能产生意想不到的后果。至关重要的是，FDA拥有全面的信息，以支持减少尼古丁产量的目标。虽然一些文献记录了对尼古丁含量不同的香烟的行为反应，但很少有研究记录对尼古丁含量较低的香烟的认知和神经反应。在年轻人中，这种信息甚至更少，这一年龄段最有可能受到尼古丁减少策略的影响。该项目的目标是通过测试减少尼古丁产量的香烟对年轻成年(18-25岁)吸烟者的影响来推进烟草监管科学。因此，利用受试者内的平衡设计，这项拟议的研究将表征吸食不同尼古丁产量(0.282、0.1、0.282或0.68毫克尼古丁)的研究香烟与参与者首选品牌香烟作为当天第一支香烟的效果。参与者将是年轻的(18-25岁)成年每日吸烟者，在隔夜戒烟后进行测试。他们将获得关于如何评价吸烟体验的自我报告，包括满足感、喜好、缓解渴望和尼古丁戒断。还将测量香烟如何影响持续注意力的能力，这是一种在戒烟者中受损的认知功能。功能磁共振成像(FMRI)将被用来提供对不同尼古丁产量的反应的大脑生物标记物，从而进一步了解主观和认知影响。这项工作将为指导烟草监管政策提供新的、关键的数据，将推动烟草监管科学领域的发展，并将为未来从监管角度对烟草产品进行评估建立创新的科学方法。

DESCRIPTION: The Family Smoking Prevention and Tobacco Control Act provides a unique opportunity for the FDA to affect an enormous improvement in public health. Granted the authority to regulate levels of nicotine, the key addictive agent in tobacco products, the FDA is i a position to help solve the problem of tobacco smoking, the leading contributor to preventable death and disease in the U.S. with an annual death toll of >400,000 individuals. Despite previous success in reducing the prevalence of smoking nationally, tobacco smoking has stabilized at about 19% of the adult population. Of even greater concern, young adults (18-25 years old) are the age group with the highest smoking prevalence in the U.S., at 34%. In order for the FDA to meet its stated priority of "reducing addiction to tobacco products", there are a number of crucial scientific questions that must be answered. Specifically, the FDA must be provided with data necessary to determine (1) the optimal level of nicotine yield in a cigarette to reduce smoking and tobacco dependence while still alleviating nicotine craving and withdrawal, and (2) how reduction to different nicotine yields would affect large subpopulations of smokers and possibly produce unintended consequences. It is vital that the FDA has comprehensive information available to support the goal of reducing nicotine yield. While some literature has documented behavioral responses to cigarettes of various nicotine yields, very little research is available to document cognitive and neural responses to reduced-nicotine cigarettes. Even less of this information is available in young adults, the age group most likely to be affected by nicotine reduction strategies. The goal of this project is to advance tobacco regulatory science by testing the effects of reduced nicotine-yield cigarettes in young adult (18-25 years old) smokers. Using a within-subjects, counterbalanced design, the proposed study will therefore characterize the effects of smoking research cigarettes with varying nicotine yields (<0.05, 0.1, 0.282, or 0.68 mg nicotine) as compared with the participant's preferred-brand cigarette as the first cigarette of the day. Participants will be young (18-25 years old) adult daily smokers, teste following overnight abstinence. Self-reports of how they evaluate the experience of smoking the different cigarettes, including satisfaction, liking, relief of craving, and nicotine withdrawal wil be obtained. Also measured will be how the cigarettes affect the ability to sustain attention, a cognitive function that is impaired in abstinent smokers. Functional magnetic resonance imaging (fMRI) will be used to provide a brain biomarker of the response to the different nicotine yields which can further inform understanding of the subjective and cognitive effects. This work will provide novel, critical data to guide tobacco regulatory policy, will advance the field of tobacco regulatory science, and will establish innovative scientific methodology for future evaluation of tobacco products from a regulatory perspective.