Grant Number:	5R01CA190347-05 Interpret this number
Primary Investigator:	Strong, David
Organization:	University Of California, San Diego
Project Title:	The Effect of Packaging on Smoking Perceptions and Behavior: a Randomized Trial
Fiscal Year:	2019

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




Evaluating US smokers' willingness to pay for different cigarette packaging designs before and after real-world exposure in a randomised trial.
Authors: Stone M. , Dimofte C. , Strong D. , Pulvers K. , Crespo N.C. , Leas E.C. , Pierce J.P. .
Source: Tobacco Control, 2023 Nov; 32(6), p. 689-695.
EPub date: 2022-03-01 00:00:00.0.
PMID: 35232793
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Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial.
Authors: Pierce J.P. , Kealey S. , Leas E.C. , Pulvers K. , Stone M.D. , Oratowski J. , Brighton E. , Villaseñor A. , Strong D.R. .
Source: Jama Network Open, 2022-06-01 00:00:00.0; 5(6), p. e2214242.
EPub date: 2022-06-01 00:00:00.0.
PMID: 35653155
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Role of affective reactivity induced by cigarette packaging including graphic warning labels: the CASA Study.
Authors: Stone M. , Strong D. , Dimofte C. , Brighton E. , Oratowski J. , Yang T. , Alkuzweny M. , Asslani A. , Velasco K. , Skipworth M. , et al. .
Source: Tobacco Control, 2021-09-12 00:00:00.0; , .
EPub date: 2021-09-12 00:00:00.0.
PMID: 34511408
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Young Adult E-cigarette Use and Retail Exposure in 6 US Metropolitan Areas.
Authors: Berg C.J. , Duan X. , Getachew B. , Pulvers K. , Crawford N.D. , Sussman S. , Ma Y. , Jones-Harrell C. , Henriksen L. .
Source: Tobacco Regulatory Science, 2021 Jan; 7(1), p. 59-75.
PMID: 34368404
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Vape shop owners'/managers' attitudes about CBD, THC, and marijuana legal markets.
Authors: Berg C.J. , Getachew B. , Pulvers K. , Sussman S. , Wagener T.L. , Meyers C. , Park A. , Dorvil S. , Patterson A. , Weber A. , et al. .
Source: Preventive Medicine Reports, 2020 Dec; 20, p. 101208.
EPub date: 2020-09-12 00:00:00.0.
PMID: 32995147
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Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.
Authors: Pierce J.P. , Strong D.R. , Stone M.D. , Villaseñor A. , Dimofte C.V. , Leas E.C. , Oratowski J. , Brighton E. , Hurst S. , Pulvers K. , et al. .
Source: Contemporary Clinical Trials, 2020-09-20 00:00:00.0; 98, p. 106152.
EPub date: 2020-09-20 00:00:00.0.
PMID: 32966877
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Tool to assess appeal-aversion response to graphic warning labels on cigarette packs among US smokers.
Authors: Stone M.D. , Dimofte C.V. , Strong D.R. , Villasenor A. , Pulvers K. , Messer K. , Pierce J.P. .
Source: Tobacco Control, 2020-04-28 00:00:00.0; , .
EPub date: 2020-04-28 00:00:00.0.
PMID: 32345609
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Exploring the Point-of-Sale Among Vape Shops Across the US: Audits Integrating a Mystery Shopper Approach.
Authors: Berg C.J. , Barker D.C. , Meyers C. , Weber A. , Park A.J. , Patterson A. , Dorvil S. , Fairman R.T. , Huang J. , Sussman S. , et al. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2020-02-28 00:00:00.0; , .
EPub date: 2020-02-28 00:00:00.0.
PMID: 32149340
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Standardised cigarette packaging may reduce the implied safety of Natural American Spirit cigarettes.
Authors: Leas E.C. , Pierce J.P. , Dimofte C.V. , Trinidad D.R. , Strong D.R. .
Source: Tobacco Control, 2018 10; 27(e2), p. e118-e123.
EPub date: 2017-12-18 00:00:00.0.
PMID: 29255011
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Helping smokers to quit.
Authors: Pierce J.P. .
Source: Bmj (clinical Research Ed.), 2018-06-27 00:00:00.0; 361, p. k2806.
EPub date: 2018-06-27 00:00:00.0.
PMID: 29950493
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Effectiveness of Pharmaceutical Smoking Cessation Aids in a Nationally Representative Cohort of American Smokers.
Authors: Leas E.C. , Pierce J.P. , Benmarhnia T. , White M.M. , Noble M.L. , Trinidad D.R. , Strong D.R. .
Source: Journal Of The National Cancer Institute, 2018-06-01 00:00:00.0; 110(6), p. 581-587.
PMID: 29281040
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Quantifying population-level health benefits and harms of e-cigarette use in the United States.
Authors: Soneji S.S. , Sung H.Y. , Primack B.A. , Pierce J.P. , Sargent J.D. .
Source: Plos One, 2018; 13(3), p. e0193328.
EPub date: 2018-03-14 00:00:00.0.
PMID: 29538396
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Which cigarettes do Americans think are safer? A population-based analysis with wave 1 of the PATH study.
Authors: Leas E.C. , Ayers J.W. , Strong D.R. , Pierce J.P. .
Source: Tobacco Control, 2017 Mar; 26(e1), p. e59-e60.
EPub date: 2016-10-14 00:00:00.0.
PMID: 27742918
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Re: Modeling the Effects of E-cigarettes on Smoking Behavior: Implications for Future Adult Smoking Prevalence.
Authors: Soneji S. , Primack B.A. , Pierce J.P. , Sung H.Y. , Sargent J.D. .
Source: Epidemiology (cambridge, Mass.), 2017 Jan; 28(1), p. e1.
PMID: 27682522
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Us Adult Smokers' Perceptions Of Australia's Cigarette Warning Labels: Variance By Warning Content And Consistency Across Socio-demographic Sub-segments
Authors: Leas E.C. , Pierce J.P. , Dimofte C.V. , Villaseñor A. , Strong D.R. .
Source: Tobacco Control, 2016-06-24 00:00:00.0; , .
PMID: 27343227
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