The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use

描述(申请人提供)：食品和药物管理局可以制定政策，将香烟中的尼古丁含量降低到不会让人上瘾的水平，这可以显著改善公众健康。必须研究香烟中尼古丁的减少如何影响密切相关的健康行为，特别是酒精使用。在美国，饮酒是导致发病和死亡的主要可预防原因，可能与吸烟者使用香烟有因果关系。因此，减少香烟中尼古丁含量的政策可能会影响酒精的使用。这项拟议的研究将是第一次临床试验，研究吸烟极低尼古丁含量(VLNC)香烟对酒精相关结果的影响。这项研究将确定吸烟VLNC香烟是否会影响饮酒、酗酒和依赖症状，以及这些影响是否在男性和女性之间有所不同。数据将作为多地点随机临床试验的一部分收集，在该试验中，参与者(N=840)将被随机分配到吸食不同尼古丁产量的香烟(即0.8毫克)或更低(即0.03毫克、0.07毫克、0.13毫克或0.25毫克)的美国通常出售的尼古丁产量。在为期6周的时间里，参与者将使用交互式语音应答(IVR)系统报告每天吸烟，每天饮酒和未研究的烟草使用情况将通过每周执行的时间表跟踪调查问卷进行评估。酒精依赖症状将在基线和第6周进行评估，尼古丁生物标记物将在基线、第2周和第6周收集指示总尼古丁暴露的尼古丁生物标记物。这项研究的目的将使用时变效应模型进行测试，该模型将利用密集的纵向数据来估计吸烟VLNC香烟对当天饮酒和酗酒水平的影响，并探索相关性是否随着时间的推移而变化。吸烟VLNC香烟对酒精依赖症状的影响将使用回归模型进行检验。将评估来自非研究烟草产品的尼古丁暴露对研究结果的影响。最后，将描述性别差异。随着FDA对美国的尼古丁法规做出决定，这一结果将对公众健康产生重要影响。此外，这项研究将通过研究香烟和酒精使用之间的关系是否与尼古丁有关，并探索可能改变这种关系的背景，为理论做出有价值的贡献。

DESCRIPTION (provided by applicant): The Food and Drug Administration can enact policies reducing the nicotine content of cigarettes to non-addictive levels, which could significantly improve public health. It is imperative to examine how nicotine reduction in cigarettes may impact closely related health behaviors, particularly alcohol use. Alcohol use is a leading preventable cause of morbidity and death in the United States and may be causally related to cigarette use among smokers. As a result, policies reducing the nicotine content in cigarettes could affect alcohol use. The proposed study will be the first clinical trial to examine how smoking very low nicotine content (VLNC) cigarettes impacts alcohol-related outcomes. The study will determine if smoking VLNC cigarettes impacts alcohol use, binge drinking, and dependence symptoms and if the effects differ between men and women. Data will be collected as part of a multi-site randomized clinical trial, in which participants (N=840) will be randomly assigned to smoke cigarettes of varying nicotine yields at (i.e., 0.8 mg) or below (i.e., 0.03 mg, 0.07 mg, 0.13 mg, or 0.25 mg) the yields typically sold in the U.S.. Over a 6-week period, participants will report daily cigarette using an Interactive Voice Response (IVR) system and daily alcohol use and non-study tobacco use will be assessed with a weekly administered timeline follow back questionnaire. Alcohol dependence symptoms will be assessed at baseline and Week 6 and nicotine biomarkers indicative of total nicotine exposure will be collected at baseline, Week 2, and Week 6. The study aims will be tested with the time- varying effects model, which will utilize the intensive longitudinal data to estimate the effects of smoking VLNC cigarettes on same-day alcohol use and binge drinking levels and explore if the associations change over time. The impact of smoking VLNC cigarettes on alcohol dependence symptoms will be examined using regression models. The impact of nicotine exposure from non-study tobacco products on study findings will be evaluated. Finally, gender differences will be described. The results will have important public health implications as the FDA makes decisions about nicotine regulations in the United States. Furthermore, the study will make valuable contributions to theory by examining if the relationship between cigarette and alcohol use is attributable to nicotine and exploring contexts that may alter the relationship.