Janet Audrain-McGovern, Ph.D.

Despite increased morbidity and mortality, 31 million adults in the United States smoke combustible cigarettes. Heated tobacco products (HTP) are an emerging nicotine delivery innovation designed to deliver nicotine with less toxins than combustible cigarettes. In 2019, the Food and Drug Administration (FDA) authorized the sale of IQOS, the only HTP tobacco product in the United States. Manufactured by Philip Morris International, IQOS is a rechargeable electronic device that produces a nicotine-containing aerosol by heating a disposable tobacco stick. While awareness and use of IQOS are increasing among cigarette smokers, the lack of data on the impact of IQOS use on cigarette smoking behaviors leaves us unable to answer fundamental questions relevant to public health and regulatory efforts. This study set out to fill this evidence gap by answering three questions. First, do cigarette smokers switch completely to IQOS, or do they dual-use these two tobacco products? Second, does IQOS use affect smokers’ intentions to quit smoking cigarettes? Third, how do indices of satisfaction with IQOS use (e.g., craving and withdrawal relief, subjective reward, and relative reinforcing value) and IQOS risk perceptions impact combustible cigarette smoking?

The University of Pennsylvania – Rutgers University TCORS Career Enhancement Core will foster a cadre of interdisciplinary researchers with the quality and breadth of experience necessary to conduct cutting-edge research related to the manufacture, distribution, and marketing of tobacco products, especially combustible tobacco products and emerging MRTPs that consumers may use similarly to combustible tobacco. Expertise will be concentrated within the theme of our center: effects of advertising, packaging and labeling on perceptions, use and exposure of combustible tobacco products. Career enhancement will be accomplished within a multi-disciplinary environment, where senior tobacco regulatory science investigators with proven success as mentors will build the research capacity of pre-doctoral fellows, postdoctoral fellows, and early-stage investigators using an interdisciplinary co-mentored model. Pilot project funds are critical to initiate tobacco regulatory science (TRS) research among pre and postdoctoral fellows, junior faculty, and investigators new to the field. As such, we will support meritorious pilot projects annually. Center-wide initiatives also include the inclusion of young investigators on all primary projects and cores to enhance their experience in scientific and administrative knowledge of conducting rigorous tobacco regulatory science research in multi-center, transdisciplinary environments.

The average smoker will attempt to quit smoking at least 30 times before abstaining for 12 months or longer. These attempts typically occur over decades of smoking, carcinogen and toxicant exposure, resulting in 480,000 deaths annually. As highlighted in the Surgeon General’s Report, helping smokers who cannot quit smoking switch to less harmful non-combustible nicotine-containing products, such as e-cigarettes, has the potential to reduce this health burden dramatically. Substituting e-cigarettes for combustible cigarettes might only be possible for persistent smokers if e-cigarettes are accessible and appealing. Harm reduction proponents have advocated for the continued availability of e-cigarette flavors to appeal to and aid cigarette smokers unable to quit with traditional methods. Yet, there are no prospective studies of the effect of flavor on initial and sustained switching from combustible to electronic cigarettes. Converging laboratory, epidemiological, and clinical research suggests that fruit-flavored e-cigarettes with nicotine may be a viable substitute for combustible cigarettes among persistent smokers. The proposed study seeks to answer two novel questions relevant to public health and the regulation of e-cigarette flavoring. First, do persistent smokers substitute fruit-flavored e-cigarettes more readily than traditional-flavored e-cigarettes (tobacco or menthol) for combustible cigarettes? Second, are fruit-flavored e-cigarettes more rewarding and reinforcing than traditional-flavored e-cigarettes, and do these effects facilitate switching? 

Nearly 70% of the ~ 30 million adult cigarette smokers in the US want to quit, and 55% report trying to quit at least once in the past year - yet, over 90% fail despite using smoking cessation medication. The average smoker will attempt to quit smoking at least 30 times before abstaining for 12 months or longer. These attempts typically occur over decades of smoking, carcinogen and toxicant exposure, resulting in 480,000 deaths annually. Novel alternatives must be considered to significantly reduce the combustible cigarette-attributable morbidity and mortality among smokers unable to quit with traditional approaches. The Surgeon General’s Report and others have underscored that helping smokers who cannot quit smoking switch to less harmful nicotine-containing products – a harm reduction approach - can dramatically reduce this health burden. E-cigarettes (ECIGS) and oral nicotine pouches (ONPs) expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking. For their harm reduction potential to be realized, fundamental questions must be answered. One, can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS? Two, what factors influence switching? Three, does one of these noncombustible alternatives expose users to lower levels of harmful chemicals than the other? Documenting the relative success of switching to ECIGS or ONPS, identifying drivers of switching, and quantifying the associated harm reduction will inform research to optimize smokers’ success in transitioning from combustible cigarettes. 

April 1, 2024 to March 31, 2028

While cigarette smoking has declined over the past two decades, cigar smoking has increased. Cigar smoking is most prevalent among young adults, with cigarillos accounting for the majority of young adult cigar use. About 13% of young adults 18-24 years old smoke cigarillos compared to 3.2% of adults > 25. Cigarillos expose young adults to comparable or higher levels of nicotine and many of the same toxicants and carcinogens as combustible cigarettes, making cigarillo use in young adults a significant public health concern. The rapid growth in available flavors has popularized cigarillo use among young adults. Research suggests that young adults prefer flavored to non-flavored tobacco cigarillos, especially those flavored to taste like fruit or other sweets. However, the factors that underlie such preferences have received little attention. Behavioral theories conceptualize the choice of sweet-flavored cigarillos to non-flavored cigarillos as a reflection of greater rewarding and relative reinforcing value. Data on the impact of sweet flavoring on combustible cigarillo use is critical to inform public health and regulatory actions aimed at reducing cigarillo use among young adults. Using validated human laboratory paradigms, the proposed study will be the first to determine if sweet-flavored cigarillos are more rewarding and reinforcing (relative and absolute) than non-flavored cigarillos among young adults.

Post-cessation weight gain (PCWG) can deter a quit attempt, precipitate smoking relapse, and contribute to health issues related to excess body weight. Most weight gain occurs within 3-6 months of quitting smoking, with weight gains averaging 9.3 pounds (5-30 pound range). PCWG has been attributed primarily to increased caloric intake due to between-meal snacking on foods high in fat and sugar. Two decades of treatment research to prevent PCWG has yielded modest success at best. The importance of identifying efficacious treatments for the prevention of PCWG is highlighted by research showing that 70 percent of treatment-seeking smokers are overweight or obese; they gain the most weight upon quitting smoking and are least accepting of PCWG. Novel theory-driven behavioral interventions that consider the mechanisms that underlie post-cessation increases in food intake may reduce PCWG and promote smoking abstinence. To advance the science and practice of interventions to reduce PCWG, we propose to target reward-related mechanisms common to smoking and palatable food intake. Through a novel application of a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+), we will increase opportunities for reinforcement and enhance the pleasure obtained from these reinforcers. A randomized clinical trial will evaluate the efficacy of BAS+ plus transdermal nicotine (TN) vs. Standard Smoking Cessation Counseling (SC) plus TN.

The growing popularity of electronic cigarette (e-cig) use among adolescents is a cause for public health and regulatory concern. Although an e-cig delivers lower levels of known toxins than a combustible cigarette, both deliver nicotine, potentially fostering cross-product use through nicotine dependence. While concerns have been raised regarding the potential for e-cigs to erode decades of adolescent smoking control efforts by promoting the uptake and persistence of combustible cigarette smoking, existing data cannot fully justify or allay these concerns. Prospective, longitudinal studies are urgently needed to address four vital questions. One, do e-cigs act as a catalyst for regular combustible cigarette smoking for youth who may not have otherwise smoked, and if so, why? Two, do e-cigs contribute to the persistence of regular combustible cigarette smoking, possibly by allowing adolescents to substitute e-cigs for combustible cigarettes in smoke-free situations? Three, which adolescents are most likely to progress to regular e-cig use and then to dual use? Four, are there subgroups of adolescents with unique longitudinal patterns of single-use and dual-use (e.g., adolescents who only use e-cigs, adolescents who only smoke cigarettes, dual users who vary in their pathway to dual use), and what are the characteristics of adolescents who have these patterns of use? We propose to address these critical gaps in the evidence base by following a prospective, longitudinal cohort of ~ 2,000 adolescents from mid (age 14 years) to late adolescence (age 18 years), measuring e-cig use, cigarette smoking, and individual and environmental risk factors for use every six months (8 waves total).