EFFECTS OF NICOTINE YIELD & NICOTINE REPLACEMENT ON VERY LOW NICOTINE CONTENT CIG

吸烟仍然是全球可预防疾病和过早死亡的主要原因。大约1 每5例死亡中就有1例与吸烟有关，大约一半的日常吸烟者将死亡 过早地患上与烟草有关的疾病。尼古丁被广泛认为是人体内的必需成分 烟草驾驶的使用和依赖。香烟中尼古丁含量的显著减少代表着 一种创新的监管战略，有可能显著降低消费并带来更大的 辞职的可能性。家庭吸烟预防和烟草控制法案(FSPTCA)使FDA能够 制定烟草产品标准，包括对香烟的允许尼古丁含量施加限制。 为了安全和成功地执行这样一项政策，一些关键问题和问题必须 被评估。其中一个主要问题是确定每支香烟的尼古丁含量适当较低的产量。 这低于令人上瘾的尼古丁“门槛”，同时也平衡了戒断效应的减弱 并最大限度地提高可接受性。研究1直接涉及到这个问题。研究1将评估三个不同的低 尼古丁产量(0.02，0.06，0.18毫克)在6周内，生成的数据将用于选择 项目1中剩余研究以及项目2和3的最佳尼古丁产量。第二个主要问题是 同时尼古丁替代疗法(NRT)是否促进向极低尼古丁的转变 内容物(VLNC)香烟。最近的证据表明，NRT可能会减少VLNC香烟的使用， 减少每支香烟的吸烟量，降低烟叶脱落率。研究2将比较 VLNC香烟对另一组吸烟者21 mg尼古丁经皮吸收的影响 戴着安慰剂贴片的VLNC香烟。第三组吸食尼古丁含量正常的香烟 而佩戴安慰剂贴片将作为额外的控制措施包括在内。 相关性(请参阅说明)： 这个项目有两个目标。研究1将确定极低尼古丁香烟的最佳产量， 减少吸烟，但也最小的不适和最大的可接受性。第二项研究将确定尼古丁 替代品有助于向尼古丁含量极低的香烟过渡。这两项研究都将增进对 使用尼古丁含量极低的香烟来减轻吸烟带来的健康负担的可行性。

Smoking remains a leading cause of preventable disease and premature death woridwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illnesses. Nicotine is widely accepted as a necessary constituent in tobacco driving use and dependence. A significant reduction in the nicotine content of cigarettes represents an innovative regulatory strategy with the potential to markedly reduce consumption and lead to greater likelihood of quitting. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. For such a policy to be implemented safely and successfully, a number of critical issues and questions must be evaluated. One primary issue is to determine an appropriately low yield of nicotine content per cigarette that is below the addictive 'threshold' of nicotine, while at the same time balances reduced withdrawal effects and maximizes acceptability. Study 1 directly bears on this issue. Study 1 will assess three different low nicotine yields (0.02, 0.06, 0.18 mg) over a 6-week period and the data generated will be used to select an optimal nicotine yield for the remaining study in Project 1 and for Projects 2 and 3. A second major issue is whether simultaneous nicotine replacement therapy (NRT) facilitates the transition to very low nicotine content (VLNC) cigarettes. Recent evidence suggests that NRT may decrease use of VLNC cigarettes, reduce the volume of smoke inhaled per cigarette, and reduce drop-out rate. Study 2 will compare the effects of VLNC cigarettes in participants on 21 mg transdermal nicotine to another group that smokers VLNC cigarettes while wearing a placebo patch. A third group smoking normal nicotine content cigarettes and wearing placebo patches will be included as an additional control. RELEVANCE (See instructions): This project has two goals. Study 1 will determine the optimal yield for very low nicotine cigarettes that leads to reduced smoking, but also minimal discomfort and maximal acceptability. Study 2 will determine if nicotine replacement aids in the transition to very low nicotine cigarettes. Both studies will advance understanding of the feasibility of using very low nicotine cigarettes to reduce the health burden of smoking.