Effect of Packaging on Smoking Perceptions and Behavior: A Randomized Trial

描述（由申请人提供）：我们正在解决FDA确定的两个关键领域：卷烟包装和标签对消费者感知和吸烟行为的影响;以及图形警告标签在传达烟草产品风险方面的有效性。我们的目的是提供一些实质性的证据，琼斯法官需要在发现对FDA的包装规定。在一项随机对照试验（RCT）中，在成功完成导入期后，我们将招募吸烟者，他们吸烟五个最受欢迎的品牌之一，并且在未来6个月内无意戒烟。所有参与者都将以折扣价从研究小组购买香烟。这项研究将生产香烟包装和重新包装香烟从吸烟者的常用品牌。三个研究组将是：a）去除所有营销材料的普通包装（PP）; B）添加图形警告图像的PP（澳大利亚型号-AM）;或c）所有营销材料未改变的标准包装（ST）。该研究包括为期三个月的购买干预和持续12个月的随访。我们的主要目的是测试从标准美国包装中删除所有烟草行业的图像是否会改变消费者对香烟的看法。目标2将测试在普通包装上添加大幅图形警告标签是否会增加人们对烟草产品危害和潜在风险的认识。目标3将测试澳大利亚模式包是否会改变烟盒的处理方式、消费模式和戒烟认知。我们在购买期间使用每日短信来确定继续购买的动机，我们还包括一个分层激励计划，以尽量减少流失。在磨合阶段，我们将进行联合营销研究，以评估不同包装元素的认知和效用，我们将在分析中使用这些。在整个研究过程中，将使用交互式短信评估来消除回忆偏差，并测量标签和营销对烟草产品感知、消费的主观影响、烟草相关危害意识、烟草使用行为和戒烟动机的急性和持续影响。在三个不同的时间点，参与者将：a）完成基于网络的问卷，B）提供唾液样本用于可替宁分析，以及c）进行基于实验室的多模态运动传感器技术评估，以对不同包的处理和与警告标签相互作用的时间进行分类。严格的设计和广泛的客观测量是对该领域目前已发表研究的重大创新，应导致烟草监管科学的重大进展。这些将使我们能够通过更复杂的统计分析来解决研究目标和假设，这些分析包括使用广义线性混合效应模型随时间的变化

DESCRIPTION (provided by applicant): We are addressing two critical areas identified by the FDA: the impact of cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the effectiveness of graphic warning labels on communicating risk of tobacco products. Our aim is to provide some of the substantial evidence that Judge Jones required in finding against the FDA packaging regulations. In a randomized controlled trial (RCT), after successful completion of a run-in period, we will enroll committed smokers who smoke one of the five most popular brands and who have no intention of quitting in the next 6-months. All participants will purchase their cigarettes at a discount from the study team. The study will manufacture cigarette packs and repackage cigarettes from the smoker's usual brand. The three study arms will be: a) a plain pack with all marketing materials removed (PP); b) PP with an added graphic warning image (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The study includes a three month purchasing intervention and continued follow-up through 12 months. Our primary Aim is to test whether removing all tobacco industry imagery from the standard US pack changes consumer perceptions of their cigarettes. Aim 2 will test whether adding large graphic warning labels to the plain packs increases the perception of harm and potential risk of tobacco products. Aim 3 will test whether the Australian model packs result in a change in the handling of cigarette packs, consumption patterns and quitting cognitions. We use daily text messaging during the purchasing period to identify motivation to continue purchasing and we have included a tiered incentive program to minimize attrition. During the run-in phase, we will conduct a conjoint marketing study to assess cognitions and utilities of the different pack elements and we will use these in our analyses. Throughout the study interactive text messaging assessments will be used to remove recall bias and measure acute and persistent impact of labeling and marketing on perceptions of tobacco products, subjective effects of consumption, awareness of tobacco- related harms, tobacco use behavior, and quitting motivation. At three separate time points, participants will: a) complete a web-based questionnaire, b) provide a saliva sample for cotinine analysis and c) undertake a lab- based multi-modal motion sensor technology assessment to classify handling of different packs and time interacting with warning labels. The rigorous design and extensive objective measurements are significant innovations on the currently published research in this field and should lead to significant advances in tobacco regulatory science. These will allow us to address the study aims and hypotheses with more sophisticated statistical analyses that include changes over time using generalized linear mixed effect models