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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA120594-04
Application #
7753892
Study Section
Biobehavioral Regulation, Learning and Ethology Study Section (BRLE)
Program Officer
Djordjevic, Mirjana V
Project Start
2007-02-01
Project End
2011-12-31
Budget Start
2010-01-01
Budget End
2010-12-31
Support Year
4
Fiscal Year
2010
Total Cost
$353,227
Indirect Cost
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Mercincavage, Melissa; Saddleson, Megan L; Gup, Emily et al. (2017) Reduced nicotine content cigarette advertising: How false beliefs and subjective ratings affect smoking behavior. Drug Alcohol Depend 173:99-106
Mercincavage, Melissa; Wileyto, E Paul; Saddleson, Megan L et al. (2017) Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards. Addiction 112:1095-1103
Mercincavage, Melissa; Souprountchouk, Valentina; Tang, Kathy Z et al. (2016) A Randomized Controlled Trial of Progressively Reduced Nicotine Content Cigarettes on Smoking Behaviors, Biomarkers of Exposure, and Subjective Ratings. Cancer Epidemiol Biomarkers Prev 25:1125-33
Falcone, M; Bansal-Travers, M; Sanborn, P M et al. (2015) Awareness of FDA-mandated cigarette packaging changes among smokers of 'light' cigarettes. Health Educ Res 30:81-6
Strasser, Andrew A; Ashare, Rebecca L; Kaufman, Madeline et al. (2013) The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev 22:382-9
Strasser, Andrew A; Kozlowski, Lynn T (2013) Cigarette marketing and packaging. Virtual Mentor 15:332-8
Ashare, Rebecca L; Norris, Catherine J; Wileyto, E Paul et al. (2013) Individual differences in positivity offset and negativity bias: Gender-specific associations with two serotonin receptor genes. Pers Individ Dif 55:469-473
Strasser, Andrew A; Tang, Kathy Z; Romer, Daniel et al. (2012) Graphic warning labels in cigarette advertisements: recall and viewing patterns. Am J Prev Med 43:41-7
Ashare, Rebecca L; Ray, Riju; Lerman, Caryn et al. (2012) Cognitive effects of the acetylcholinesterase inhibitor, donepezil, in healthy, non-treatment seeking smokers: A pilot feasibility study. Drug Alcohol Depend 126:263-7
Ashare, Rebecca L; Tang, Kathy Z; Mesaros, A Clementina et al. (2012) Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. J Psychopharmacol 26:1383-90

Showing the most recent 10 out of 14 publications