Tuesday, September 26, 2023
9/26/2023
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
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