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

一项有希望的战略，以减少吸烟相关疾病的公共卫生负担，目前正在 FDA烟草产品中心的考虑是通过减少烟草的成瘾性 将香烟中的尼古丁含量降低到足以维持成瘾的水平。然而，有几个关键 为了了解这样的政策对我们的影响，必须解决的悬而未决的问题 目前的吸烟人口，他们越来越多地使用电子烟和传统香烟。什么是 在吸烟者使用含有尼古丁的电子烟的情况下，烟草香烟的尼古丁滥用责任阈值 要香烟吗？尼古丁的最低剂量是多少，才能产生明显的奖励效果？ 会导致强迫性使用吗？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较年轻、较轻的吸烟者？拟议的研究将解决 通过将320名吸烟者(包括重度、长期吸烟者和较轻、较年轻吸烟者)随机分配到 从他们通常品牌的香烟转向焦油产量相似但五种不同的研究香烟 尼古丁含量。所有参与者将可以在12周内同时使用电子烟 曝光期。我们将评估香烟尼古丁含量对滥用责任衡量标准的影响， 包括每日香烟消费量、吸烟奖励和尼古丁等依赖指标 戒断症状。在实验室环节，我们将测量尼古丁阈值，以检测和 认识到吸烟令人上瘾、有益的影响。这项研究旨在帮助FDA确定目标 尼古丁阈值不会吸引年轻人吸烟，也不会导致既往吸烟者复发。 此外，我们将确定在不诱导的情况下可以容忍的香烟尼古丁减少量。 吸烟者的不满，与FDA设计逐步减少尼古丁有关的信息 可以在没有广泛反对的情况下实施的政策。从这个项目中获得的知识将 大大增加了我们对尼古丁成瘾的了解，并将有助于制定FDA与该法规相关的政策 烟草中的尼古丁含量。最终，设计良好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死亡人数。

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.