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

吸烟仍然是全世界可预防疾病和过早死亡的主要原因。约1 每5例死亡中就有1例与吸烟有关，每天吸烟的人中约有一半会死亡。 与烟草有关的疾病。尼古丁被广泛认为是一种必需的成分， 烟草的使用和依赖。香烟中尼古丁含量的显著降低代表着 创新的监管战略，有可能显著减少消费， 退出的可能性。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，包括限制香烟的尼古丁含量。 为了安全和成功地实施这样的政策，必须解决一些关键问题和问题。 被评价。一个主要问题是确定每支香烟的尼古丁含量适当低 这是低于尼古丁成瘾的“阈值”，同时平衡减少戒断作用 最大限度地提高可接受性。研究1直接涉及这一问题。研究1将评估三种不同的低 尼古丁产量（0.02，0.06，0.18 mg）在6周的时间内，产生的数据将用于选择一个 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 同步尼古丁替代疗法（NRT）是否有助于向极低尼古丁水平过渡 含量（VLNC）香烟。最近的证据表明，NRT可能会减少VLNC香烟的使用， 减少每支烟的吸烟量，降低辍学率。研究2将比较 VLNC香烟对参与者21 mg经皮尼古丁的影响 VLNC香烟，同时佩戴安慰剂贴片。第三组吸烟正常尼古丁含量的香烟 并且将包括佩戴安慰剂贴剂作为额外的对照。 相关性（参见说明）： 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。研究2将确定尼古丁是否 替代品有助于过渡到尼古丁含量非常低的香烟。这两项研究将促进对 使用尼古丁含量极低的香烟以减轻吸烟对健康造成的负担的可行性。

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.