Effects of cigar flavors on measures of abuse liability among young adults

项目总结 在美国，烟草使用每年造成近50万人死亡。减少 在这一死亡人数上，美国食品和药物管理局(FDA)被授予了监管权力 烟草在2009年。这一权力仅限于日益流行的雪茄。 2014年，FDA提议对这些产品进行更广泛的监管控制，包括调味雪茄。 雪茄口味的可获得性，以及其他特征，与销量的增加有关 和消费，其中青年/青壮年和某些种族/民族的增幅最大 少数族裔。 目前还没有研究量化雪茄口味对滥用倾向的影响--在多大程度上 精神活性药物或制剂将用于非医疗目的，滥用将导致 依赖。这些证据对于减少年轻人/年轻人吸烟至关重要，他们已经 试验的高风险和与FDA优先事项的相关性。 目前的研究旨在通过系统地检查这一影响来解决这一关键的证据差距 最受欢迎的雪茄品牌布莱克和温德(B&M)的四种口味中，有三种是滥用 年轻成人传统烟草(CTC)吸烟者的易感性：1)通过以下途径接触尼古丁 唾液浓度；2)行为任务的断点，即个体在金钱之间做出选择 或雪茄泡芙；3)雪茄效果的主观衡量。目前的四氯化碳吸烟者(N=25；年龄18-21岁 年)，谁是没有经验的雪茄烟民(≤5次)，将完成5拉丁方排序， 不同吸烟产品的受试者实验室条件不同：自有品牌CTC或B&M雪茄 原味、苹果味、奶油味或葡萄酒味。 拟议的研究与RFA-OD-15-004中阐明的FDA-CTP优先事项密切一致，包括 雪茄的启动、使用(和多次使用)、感知、依赖和毒性以及 加香烟草高危人群烟草产品特性的初步研究 使用。这项工作的结果将为即将出台的对雪茄的具体监管以及 提供了一种可用于评价其他烟草产品中香料影响的方法。 我们将利用从这项研究中建立的证据基础来测试R01提案 广泛的政策，以规范烟草产品的风味。

PROJECT SUMMARY Tobacco use contributes to nearly half a million deaths in the United States annually. To reduce this death toll, the Food and Drug Administration (FDA) was granted regulatory authority over tobacco in 2009. This authority was limited with respect to cigars, which are increasingly popular. In 2014, FDA proposed broader regulatory control over these products, including flavored cigars. The availability of cigar flavors, among other characteristics, has been linked to increased sales and consumption, with the largest increases among youth/young adults and certain racial/ethnic minorities. No studies exist quantifying the effect of cigar flavors on abuse liability—the degree to which a psychoactive drug or formulation would be used for nonmedical purposes and that abuse would lead to dependence. Such evidence is essential to reducing cigar smoking among youth/young adults, who have a high risk of experimentation and relevance to FDA priorities. The current study aims to address this critical evidence gap by systematically examining the effect of four flavors of Black & Mild (B&M), the most popular cigar brand, on three measures of abuse liability in young adult conventional tobacco cigarette (CTC) smokers: 1) exposure to nicotine via saliva concentrations; 2) breakpoint from behavioral tasks where individuals choose between money or cigar puffs; 3) and subjective measures of cigar effects. Current CTC smokers (N=25; aged 18-21 years), who are inexperienced cigar smokers (≤5 times), will complete 5 Latin-square ordered, within-subject laboratory conditions that differ by product smoked: own brand CTC or B&M cigars in original, apple, cream, or wine flavor. The proposed study closely aligns with FDA-CTP priorities articulated in RFA-OD-15-004 including cigar initiation, use (and multiple use), perceptions, dependence and toxicity and the impact of tobacco product characteristics on initiation among populations most at-risk for flavored tobacco use. Results from this work will inform the impending regulation of cigars specifically as well as provide a method that can be used to evaluate the influence of flavors in other tobacco products. We will leverage the evidence base established from this research into a R01 proposal to test a broad spectrum of policies to regulate tobacco product flavors.