Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use

一项减少吸烟相关疾病的公共卫生负担的有希望的战略，目前正在 FDA烟草制品中心的考虑是通过减少烟草的成瘾性， 香烟中的尼古丁含量低于使人上瘾的水平。然而，关键 为了理解这样一项政策对我们的影响，必须解决一些悬而未决的问题。 目前的吸烟人口，越来越多地使用电子烟和传统香烟。是什么 在吸烟者使用含尼古丁的电子烟的情况下，烟草卷烟的尼古丁滥用责任阈值 香烟吗什么是尼古丁的最低剂量，可以产生可辨别的奖励效果， 导致强迫性吸毒尼古丁滥用责任门槛是否也适用于长期重度吸烟者 适用于对尼古丁更敏感的年轻、较轻的吸烟者？拟议的研究将解决 通过随机抽取320名吸烟者（包括长期重度吸烟者和较轻的年轻吸烟者）， 从他们通常的香烟品牌转向研究焦油量相似但五种不同的香烟 尼古丁含量所有参与者将在12周内同时使用电子烟 暴露期。我们将评估香烟尼古丁含量对滥用倾向的影响， 包括每日吸烟量、吸烟奖励和依赖性指标，如尼古丁 戒断症状在实验室阶段，我们将测量尼古丁阈值， 认识到吸烟的成瘾性和奖励作用。这项研究旨在帮助FDA确定一个目标 尼古丁阈值不会吸引年轻人吸烟或诱导前吸烟者复吸。 此外，我们将确定在不诱导吸烟者吸烟的情况下， 吸烟者的不满，与FDA设计逐步减少尼古丁相关的信息 一个可以在没有广泛反对的情况下实施的政策。从该项目中获得的知识将 这将大大增加我们对尼古丁成瘾的了解，并将有助于制定与该法规相关的FDA政策。 烟草的尼古丁含量。最终，一个精心设计的尼古丁减少政策有可能 大大减少吸烟造成的巨大死亡和疾病。

A promising strategy for reducing the public health burden of smoking-related disease, currently under consideration by the FDA's Center for Tobacco Products, is to reduce the addictiveness of tobacco by reducing the nicotine content of cigarettes to below a level that will sustain addiction. There are, however, key unanswered questions that must be addressed in order to understand the impact of such a policy on our current smoking population, who increasingly use both e-cigarettes and conventional cigarettes. What is the nicotine abuse liability threshold for tobacco cigarettes in a context where smokers use nicotine-containing e- cigarettes? What are the minimal doses of nicotine that can produce discriminable rewarding effects and engender compulsive use? Will a nicotine abuse liability threshold applicable to long-time, heavy smokers also apply to younger, lighter smokers who are more sensitive to nicotine? The proposed research will address these issues by randomizing 320 smokers (both heavy, long-time smokers and lighter, younger smokers) to switch from their usual brands of cigarettes to research cigarettes with similar tar yields but five different nicotine contents. All participants will have access to concurrent use of e-cigarettes during the 12-week exposure period. We will assess the effects of cigarette nicotine content on measures of abuse liability, including daily cigarette consumption, smoking reward and measures of dependence, such as nicotine withdrawal symptoms. In laboratory sessions, we will measure nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking. This study is designed to help the FDA identify a target nicotine threshold that will not attract young people to smoking or induce relapse in former smokers. Additionally, we will determine the level of cigarette nicotine reduction that will be tolerated without inducing dissatisfaction in smokers, information that is relevant to the FDA for designing a stepwise nicotine reduction policy that can be implemented without widespread objections. The knowledge gained from this project will greatly increase our knowledge of nicotine addiction and will help frame an FDA policy relating to the regulation of the nicotine content of tobacco. Ultimately, a well-designed nicotine reduction policy has the potential to greatly reduce the enormous toll of death and disease caused by cigarette smoking.