Smoking topography and harm exposure in a new PREP

描述(申请人提供)：大约25%的美国成年人口是目前的吸烟者，尽管许多人试图戒烟，但大多数都失败了。作为另一种选择，一些吸烟者使用可能减少暴露的产品(PREP)。然而，先前的减害产品，如轻烟，已被证明是一场公共卫生灾难。致癌物质暴露研究和流行病学数据表明，补偿性吸烟行为可以使轻香烟与普通香烟一样有害。因此，重要的是要了解人们是如何使用Prep的，并评估这与他们的伤害暴露有何关系。Quest(R)香烟是一种新型的香烟，它使用转基因烟草，通过销售尼古丁含量逐渐降低的香烟来提供一种“逐步实现无尼古丁的方法”：0.6毫克、0.3毫克和0.05毫克。这项研究的主要目的是调查香烟尼古丁水平的递减对吸烟地形和危害暴露措施的影响。这项研究将是一项受试者内的开放标签设计，对象为210名目前没有兴趣戒烟的吸烟者。参与者将被随机分为三种情况之一：1)继续抽自己品牌的香烟(对照组)；2)按降级顺序吸烟Quest(R)香烟，将香烟尼古丁水平从0.6毫克逐渐降低到0.3 mg，再到0.05 mg(Quest(R)降级)；或3)以非降级随机顺序吸烟Quest(R)香烟，在受试者之间平衡(Quest(R)非降级)。这项研究将包括四个阶段，首先是对所有参与者进行为期5天的自有品牌吸烟阶段，然后是三种吸烟条件之一。对于那些吸食Quest(R)香烟的人来说，香烟的尼古丁水平将每10天改变一次，要么是递减的，要么是随机的。主要的行为结果是吸烟的地形；具体地说，总吸烟量和平均吸烟量，将在每一次会议上进行评估。评估吸烟暴露的一氧化碳和尿液生物标记物也将得到评估。在基线阶段，参与者将观看Quest(R)广告并完成对产品预期的调查，以确定对Quest(R)香烟的看法对随后的吸烟行为的影响。这项研究有几个重要的公共卫生影响。它将决定如何实际使用新的备考。它还将确定产品使用与危害暴露的关系。最后，它将确定哪些人最容易受到吸烟地形变化的影响，这些变化可能会增加危害暴露。

DESCRIPTION (provided by applicant): Approximately 25% of the adult US population are current smokers, and although many try to quit, most fail. As an alternative, some smokers use potentially reduced exposure products (PREPs). However, prior harm reduction products, such as light cigarettes, have proven to be a public health disaster. Carcinogen exposure studies and epidemiologic data show that compensatory smoking behavior can make light cigarettes as harmful as regular cigarettes. Therefore, it is important to understand how people use PREPs and to assess how this relates to their harm exposure. Quest(r) cigarettes are a new PREP that uses genetically modified tobacco to provide a "step-down approach to becoming nicotine-free" by marketing cigarettes with progressively lower levels of nicotine: 0.6 mg, 0.3 mg and 0.05 mg. The primary aim of the study is to investigate the effect of progressive decreases in cigarette nicotine level on smoking topography and harm exposure measures. The study will be a within-subject, open-label design of 210 smokers not currently interested in quitting. Participants will be randomized to one of three conditions: 1) continue to smoke their own brand (control); 2) smoke Quest(r) cigarettes in the step-down order, progressively decreasing cigarette nicotine level from 0.6 mg, to 0.3 mg, to 0.05 mg (Quest(r) step-down); or 3) smoke Quest(r) cigarettes in a non-step down random order, counter balanced across subjects (Quest(r) non-step- down). The study will consist of four stages beginning with a 5-day own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest(r) cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography; specifically total and mean puff volume, which will be assessed at each session. Carbon monoxide to assess smoke exposure, and urinary biomarkers, will also be assessed. At baseline, participants will view Quest(r) advertisements and complete a survey of product expectations to determine the impact of beliefs about Quest(r) cigarettes on subsequent smoking behavior. This study has several important public health implications. It will determine how a new PREP is actually used. It will also determine how product use relates to harm exposure. Finally, it will identify those most susceptible to changes in smoking topography that may increase harm exposure.