Tobacco use contributes to nearly half a million deaths in the United States annually. To reduce this death toll, the Food and Drug Administration (FDA) was granted regulatory authority over tobacco in 2009. This authority was limited with respect to cigars, which are increasingly popular. In 2014, FDA proposed broader regulatory control over these products, including flavored cigars. The availability of cigar flavors, among other characteristics, has been linked to increased sales and consumption, with the largest increases among youth/young adults and certain racial/ethnic minorities. No studies exist quantifying the effect of cigar flavors on abuse liability?the degree to which a psychoactive drug or formulation would be used for nonmedical purposes and that abuse would lead to dependence. Such evidence is essential to reducing cigar smoking among youth/young adults, who have a high risk of experimentation and relevance to FDA priorities. The current study aims to address this critical evidence gap by systematically examining the effect of four flavors of Black & Mild (B&M), the most popular cigar brand, on three measures of abuse liability in young adult conventional tobacco cigarette (CTC) smokers: 1) exposure to nicotine via saliva concentrations; 2) breakpoint from behavioral tasks where individuals choose between money or cigar puffs; 3) and subjective measures of cigar effects. Current CTC smokers (N=25; aged 18-21 years), who are inexperienced cigar smokers (?5 times), will complete 5 Latin-square ordered, within-subject laboratory conditions that differ by product smoked: own brand CTC or B&M cigars in original, apple, cream, or wine flavor. The proposed study closely aligns with FDA-CTP priorities articulated in RFA-OD-15-004 including cigar initiation, use (and multiple use), perceptions, dependence and toxicity and the impact of tobacco product characteristics on initiation among populations most at-risk for flavored tobacco use. Results from this work will inform the impending regulation of cigars specifically as well as provide a method that can be used to evaluate the influence of flavors in other tobacco products. We will leverage the evidence base established from this research into a R01 proposal to test a broad spectrum of policies to regulate tobacco product flavors.
Flavored cigars have been linked to increased sales and consumption, with the largest increases among youth/young adults and certain racial/ethnic minorities. This study will provide important evidence regarding the abuse liability of cigar flavors that is critical to inform the impending federal regulations of cigars and other flavored tobacco products.
| Wall, Catherine S; Bono, Rose S; Lester, Rebecca C et al. (2018) Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol. BMJ Open 8:e023850 |
| Nicksic, Nicole E; Snell, L Morgan; Rudy, Alyssa K et al. (2017) Tobacco Marketing, E-cigarette Susceptibility, and Perceptions among Adults. Am J Health Behav 41:579-590 |
