Evaluating New Nicotine Standards for Cigarettes - Project 1

评估卷烟新尼古丁标准 - 项目 1

• 批准号: 9889096
• 负责人: DOROTHY K HATSUKAMI
• 金额: $ 177.09万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9889096
• 关键词: Abstinence; Address; Affect; Age; American; Biological Markers; Blinded; Cessation of life; Characteristics; Cigarette; Complement; Complex; Data; Dependence; Disease; Dose; Electronic cigarette; Environment; Ethnic group; Family Smoking Prevention and Tobacco Control Act; Fibrinogen; Goals; Grant; Institutes; Measures; Mediating; Methods; Monitor; Nicotine; Participant; Pattern; Policies; Population; Price; Public Health; Randomized; Relapse; Reporting; Research Design; Research Priority; Severities; Smoke; Smokeless Tobacco; Smoker; Smoking; Smoking Behavior; Source; Specific qualifier value; Surgeon; Tobacco; Tobacco use; Toxicant exposure; United States; United States Food and Drug Administration; Withdrawal; addiction; authority; cigarette smoke; cigarette smoking; cost; experience; inclusion criteria; innovation; male; nicotine exposure; novel; predicting response; racial and ethnic; response; sex; smoking abstinence; smoking addiction; snus; tobacco control; tobacco exposure; tobacco products; tool; toxicant; uptake; voucher

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.

项目摘要/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，“在美国，烟草使用造成的死亡和疾病负担 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 消除它们的使用将极大地减轻这一负担。“虽然全面控烟 这些措施在减少吸烟方面产生了重大影响，因为近五分之一的美国人仍然 为了减少吸烟，需要采用新的烟草控制方法来减少燃烧烟草产品的使用。一 通过2009年的家庭授予食品和药物管理局的最强大的工具之一 《吸烟预防和烟草控制法》是制定产品标准的权威机构，它 包括尼古丁的标准，使香烟的成瘾性降至最低。这一监管政策可能 通过最大限度地减少从实验性香烟使用到 依赖，促进戒烟尝试，减少复发的发生。到目前为止，研究 研究将尼古丁降至极低水平(例如0.4毫克/克尼古丁)的效果是 与正常的尼古丁含量相比，吸烟和依赖的减少是有希望的 香烟和戒烟尝试的增加。然而，这些研究中的大多数，尽管很有力 实验上，不是在复杂市场的背景下进行的，因此结果 这些研究可能不能充分代表减少尼古丁对公众健康的全部影响 香烟。例如，这些研究免费提供学习用香烟，不鼓励使用 其他烟草或尼古丁产品，使吸烟者对尼古丁剂量视而不见，并具有限制性包含 标准。项目1将绕过这些限制，通过提供 参与者可以访问试验性市场，在那里他们将获得可以 交换研究用香烟(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，并通过扩大 纳入研究的标准。更具体地说，受试者(每组N=350)将是随机的 分配给：1)尼古丁含量极低的香烟(VLNC；0.4毫克/克)以及非燃烧香烟 烟草/尼古丁产品或2)正常尼古丁含量香烟(NNC；15.8毫克/克)以及非 燃烧的烟草/尼古丁产品。我们假设VLNC香烟的状况将导致：1) 更多地使用非燃烧产品；2)减少吸烟；3)减少接触烟草- 相关毒物；以及4)更多的戒烟天数。我们还假设 与NNC相比，VLNC的积极影响较小，而替代的积极影响更大 与NNC条件下的非燃烧产物相比。最后，我们假设特定的群体 吸烟者将更有可能寻求和使用非燃烧产品(例如，男性，更依赖于 香烟)。本项目将补充项目2和项目3，以自然主义而不是 机械时尚，吸烟者随机寻求的替代产品特征的类型 VLNC和NNC香烟以及可能影响其使用和反应的受试者特征 多个烟草产品市场。