Evaluating New Nicotine Standards for Cigarettes - Project 1

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PROJECT SUMMARY/ABSTRACT In the United States, there are 44 million smokers and about 500,000 tobacco related deaths yearly. The 2014 Surgeon General's Report stated, “ The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.” Although comprehensive tobacco control measures have had a significant impact in reducing smoking, because nearly 1 out 5 Americans still smoke, novel tobacco control approaches to reduce combusted tobacco product use are needed. One of the most powerful tools granted to the Food and Drug Administration through the 2009 Family Smoking Prevention and Tobacco Control Act is the authority to establish product standards, which includes standards for nicotine to render the cigarette minimally addictive. This regulatory policy could have a profound impact on public health by minimizing the transition from experimental cigarette use to dependence, facilitating quit attempts, and reducing the occurrence of relapse. To date, studies conducted examining the effects of reducing nicotine to very low levels (e.g., 0.4 mg/g nicotine) are promising and show a reduction in smoking and dependence relative to normal nicotine content cigarettes and an increase in quit attempts. However, the majority of these studies, although strong experimentally, were not conducted in the context of a complex marketplace and as such the results from these studies may not adequately represent the full public health impact of reducing nicotine in cigarettes. For example, these studies provided study cigarettes at no cost, discouraged the use of other tobacco or nicotine products, blinded smokers to the dose of nicotine and had restrictive inclusion criteria. Project 1 will circumvent these limitations, simulating the “real world” environment by providing participants access to an experimental marketplace where they will be given vouchers that can be exchanged for study cigarettes (varying in nicotine content) and non-combusted tobacco/nicotine products or cash, by informing participants about the nicotine content in cigarettes, and by broadening the criteria for study inclusion. More specifically, subjects (N=350 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non- combusted tobacco/nicotine products. We hypothesize that the VLNC cigarette condition will lead to: 1) greater use of non-combusted products; 2) fewer cigarettes smoked; 3) less exposure to tobacco- related toxicants; and 4) greater number of days of cigarette abstinence. We also hypothesize that VLNC will be associated with less positive effects than NNC, and greater positive effects of alternative non-combusted products than in the NNC condition. Finally, we hypothesize that specific groups of smokers will be more likely to seek and use non-combusted products (e.g., male, more dependent on cigarettes). This project will complement Projects 2 and 3 by examining, in a naturalistic rather than mechanistic fashion, the type of alternative product characteristics sought by smokers randomized to VLNC and NNC cigarettes and subject characteristics that might influence use of and responses to a multiple tobacco product marketplace.