Amanda J. Quisenberry, Ph.D. - US grants

PROJECT SUMMARY Cigarette smoking is the leading preventable cause of mortality and morbidity. A central contributor to the abuse liability, or addictive potential, of tobacco products is the addition of characterizing flavors. The Food and Drug Administration (FDA) has recently been afforded the authority to regulate the availability of flavored tobacco products, including e-cigarettes and menthol-flavored cigarettes. The removal of menthol-flavored cigarettes would benefit public health, however, menthol cigarette smokers may quit or switch to another product, or substitute, and little is know regarding product choices if a flavor ban were to occur or how flavor- related text and imagery on tobacco product packaging contributes to the appeal and abuse liability of tobacco products. Behavioral economic measures of demand and substitutability evaluated in the Experimental Tobacco Marketplace (ETM) in combination with eye-tracking technology are ideally suited to address these questions prior to the implementation of regulation. The ETM is used in clinical abuse liability screening and mimics an online storefront. Eye-tracking technology is a precise, objective measure of visual attention, which contributes to decision making, including product choice. The current proposal aims to simultaneously utilize the ETM and eye tracking in menthol cigarette smokers (n=179) to determine: 1) the abuse liability and level of substitutability of regular cigarettes and e-cigarettes when menthol-flavored cigarettes are removed from the marketplace, 2) the abuse liability of menthol and non-menthol cigarettes and substitutability of e-cigarettes when flavored e-cigarette availability is manipulated, and 3) the association between abuse liability and visual attention to flavored-product text and imagery. A repeated measure 2 (cigarette availability: menthol or non- menthol) X 2 (e-cigarette availability: five flavors or both tobacco and unflavored) design will be implemented to evaluate the effects of flavored tobacco product availability on abuse liability and its association with the appeal of flavor imagery and text on packaging. The proposed study aligns with the FDA priorities outlined in RFA-OD- 17-008, specifically the areas of behavior and addiction. Results from this work will inform the outcomes of future flavored tobacco product regulation and a future R01 proposal assessing a greater variety of product standards, including flavor and packaging manipulations.

PROJECT SUMMARY Cigarette smoking is the leading preventable cause of mortality and morbidity. A central contributor to the abuse liability, or addictive potential, of tobacco products is the addition of characterizing flavors. The Food and Drug Administration (FDA) has recently been afforded the authority to regulate the availability of flavored tobacco products, including e-cigarettes and menthol-flavored cigarettes. The removal of menthol-flavored cigarettes would benefit public health, however, menthol cigarette smokers may quit or switch to another product, or substitute, and little is know regarding product choices if a flavor ban were to occur or how flavor- related text and imagery on tobacco product packaging contributes to the appeal and abuse liability of tobacco products. Behavioral economic measures of demand and substitutability evaluated in the Experimental Tobacco Marketplace (ETM) in combination with eye-tracking technology are ideally suited to address these questions prior to the implementation of regulation. The ETM is used in clinical abuse liability screening and mimics an online storefront. Eye-tracking technology is a precise, objective measure of visual attention, which contributes to decision making, including product choice. The current proposal aims to simultaneously utilize the ETM and eye tracking in menthol cigarette smokers (n=179) to determine: 1) the abuse liability and level of substitutability of regular cigarettes and e-cigarettes when menthol-flavored cigarettes are removed from the marketplace, 2) the abuse liability of menthol and non-menthol cigarettes and substitutability of e-cigarettes when flavored e-cigarette availability is manipulated, and 3) the association between abuse liability and visual attention to flavored-product text and imagery. A repeated measure 2 (cigarette availability: menthol or non- menthol) X 2 (e-cigarette availability: five flavors or both tobacco and unflavored) design will be implemented to evaluate the effects of flavored tobacco product availability on abuse liability and its association with the appeal of flavor imagery and text on packaging. The proposed study aligns with the FDA priorities outlined in RFA-OD- 17-008, specifically the areas of behavior and addiction. Results from this work will inform the outcomes of future flavored tobacco product regulation and a future R01 proposal assessing a greater variety of product standards, including flavor and packaging manipulations.

ABSTRACT Cigarillos are popular among youth and young adults, and flavors predominate in this tobacco product type. Despite carrying the same level of health risk, flavored tobacco products are misperceived by youth as being less harmful than unflavored products. A gap in the current literature exists for characterizing flavors in cigarillos and their impact on product appeal, attention to marketing, product perceptions, abuse liability, and subsequent use behavior among youth and young adults. It has yet to be determined whether the removal of flavors from cigarillos would results in cessation or substitution of another tobacco product, such as e-cigarettes, and whether that choice would be more influenced by perceptions of appeal or perceptions of risk. To accomplish this, we have proposed three integrated aims to gather data to inform CTP regulation strategies on flavored tobacco, specifically for cigarillo products; throughout the proposed research, data on JUUL will be gathered as a highly popular alternative product with potential substitutability. First, drawing from an existing Young Cigarillo User Sample, we will evaluate perceptions of flavors on appeal, risk perceptions, and addictiveness of cigarillos and other tobacco products among youth and young adult cigarillo users. Within the same sample, we will experimentally examine differences in visual attention and risk perceptions of flavored and unflavored cigarillo and JUUL advertisements among youth and young adult cigarillo users; non-users will be added to explore whether effects are modified by user type. Next, we will use a complex Experimental Tobacco Marketplace to evaluate the abuse liability/addictive potential of flavored versus unflavored cigarillos while simultaneously evaluating substitutability of JUUL e-cigarettes. Through these three aims, this proposal employs rigorous biobehavioral and behavioral economic methods to gather data that will create a foundation to inform intervention-focused research. Now that cigarillos are subject to FDA regulatory authority, these findings will be responsive to the ANPRM on the role of flavors in youth and young adult cigarillo use, and will inform policy development regarding product standards and advertising to reduce both appeal and abuse liability and to accurately inform consumers regarding cigarillo risks to health.