Evaluating New Nicotine Standards for Cigarettes - Project 1

项目总结/摘要 在美国，每年有4400万吸烟者和大约50万与烟草有关的死亡。 2014年卫生局局长的报告指出，“烟草使用造成的死亡和疾病负担 在美国，绝大多数是由香烟和其他燃烧的烟草产品造成的;迅速 消除它们的使用将大大减轻这一负担。”虽然全面控烟 这些措施对减少吸烟产生了重大影响，因为近五分之一的美国人仍然 吸烟，需要新的烟草控制方法来减少燃烧的烟草产品的使用。一 通过2009年家庭授予食品和药物管理局的最强大的工具 预防吸烟和烟草控制法是建立产品标准的权威， 包括尼古丁的标准，以使香烟最小程度地上瘾。这一监管政策可以 通过最大限度地减少从实验性吸烟到吸烟的过渡， 依赖，促进戒烟尝试，并减少复发的发生。迄今为止，研究 进行了检查将尼古丁降低到非常低的水平（例如，0.4 mg/g尼古丁） 与正常尼古丁含量相比， 吸烟和戒烟尝试的增加。然而，这些研究中的大多数，虽然强有力， 实验上，没有在复杂的市场环境中进行，因此， 这些研究可能不足以代表减少尼古丁对公众健康的全部影响， 香烟例如，这些研究免费提供研究香烟，不鼓励使用 其他烟草或尼古丁产品，使吸烟者对尼古丁的剂量不知情， 的搜索.项目1将绕过这些限制，通过提供以下内容来模拟“真实的世界”环境： 参与者可以进入一个实验市场，在那里他们将获得可以 交换为研究香烟（尼古丁含量不同）和非燃烧烟草/尼古丁 产品或现金，通过告知参与者香烟中的尼古丁含量， 研究入选标准。更具体地，将受试者（每组N=350）随机分组。 分配给：1）尼古丁含量极低的香烟（VLNC; 0.4 mg/g）沿着未燃烧的 烟草/尼古丁产品或2）尼古丁含量正常的香烟（NNC; 15.8 mg/g）沿着非尼古丁产品。 燃烧的烟草/尼古丁产品。我们假设VLNC香烟条件将导致：1） 更多地使用非燃烧产品; 2）更少地吸烟; 3）更少地接触烟草- 相关毒物;和4）更多的戒烟天数。我们还假设， VLNC与NNC相比，其积极影响较小，而替代品的积极影响较大。 非燃烧产物比在NNC条件下。最后，我们假设，特定群体的 吸烟者将更可能寻求和使用非燃烧产品（例如，男性，更依赖于 香烟）。该项目将补充项目2和项目3，通过研究，在一个自然，而不是 机械时尚，吸烟者随机选择的替代产品特征类型， VLNC和NNC香烟以及可能影响使用和响应的受试者特征 多种烟草产品市场。

PROJECT SUMMARY/ABSTRACT In the United States, there are 44 million smokers and about 500,000 tobacco related deaths yearly. The 2014 Surgeon General's Report stated, “ The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.” Although comprehensive tobacco control measures have had a significant impact in reducing smoking, because nearly 1 out 5 Americans still smoke, novel tobacco control approaches to reduce combusted tobacco product use are needed. One of the most powerful tools granted to the Food and Drug Administration through the 2009 Family Smoking Prevention and Tobacco Control Act is the authority to establish product standards, which includes standards for nicotine to render the cigarette minimally addictive. This regulatory policy could have a profound impact on public health by minimizing the transition from experimental cigarette use to dependence, facilitating quit attempts, and reducing the occurrence of relapse. To date, studies conducted examining the effects of reducing nicotine to very low levels (e.g., 0.4 mg/g nicotine) are promising and show a reduction in smoking and dependence relative to normal nicotine content cigarettes and an increase in quit attempts. However, the majority of these studies, although strong experimentally, were not conducted in the context of a complex marketplace and as such the results from these studies may not adequately represent the full public health impact of reducing nicotine in cigarettes. For example, these studies provided study cigarettes at no cost, discouraged the use of other tobacco or nicotine products, blinded smokers to the dose of nicotine and had restrictive inclusion criteria. Project 1 will circumvent these limitations, simulating the “real world” environment by providing participants access to an experimental marketplace where they will be given vouchers that can be exchanged for study cigarettes (varying in nicotine content) and non-combusted tobacco/nicotine products or cash, by informing participants about the nicotine content in cigarettes, and by broadening the criteria for study inclusion. More specifically, subjects (N=350 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non- combusted tobacco/nicotine products. We hypothesize that the VLNC cigarette condition will lead to: 1) greater use of non-combusted products; 2) fewer cigarettes smoked; 3) less exposure to tobacco- related toxicants; and 4) greater number of days of cigarette abstinence. We also hypothesize that VLNC will be associated with less positive effects than NNC, and greater positive effects of alternative non-combusted products than in the NNC condition. Finally, we hypothesize that specific groups of smokers will be more likely to seek and use non-combusted products (e.g., male, more dependent on cigarettes). This project will complement Projects 2 and 3 by examining, in a naturalistic rather than mechanistic fashion, the type of alternative product characteristics sought by smokers randomized to VLNC and NNC cigarettes and subject characteristics that might influence use of and responses to a multiple tobacco product marketplace.