||5R01CA154992-03 Interpret this number
||Medical University Of South Carolina
||A Novel Trial of Smokeless Tobacco for Cessation Induction in Unmotivated Smokers
DESCRIPTION (provided by applicant): Potentially reduced exposure products (PREPs) represent the latest strategy by the tobacco industry to reduce risks associated with tobacco use. The most recent generation of PREPs includes oral, non-combustible smokeless products. Although a comprehensive risk profile remains unclear, a number of short-term lab studies of toxicant exposure suggest smokeless tobacco could offer reduced harm as compared to conventional cigarettes. In contrast, there is limited evidence to determine if PREPs ultimately undermine or promote public health. More specifically, few randomized clinical trials (RCTs) have examined the impact of PREPs, particularly oral smokeless tobacco, on smoking and quit behavior (e.g., quit attempts). This critical issue remains unanswered, and yet is the source of contentious debate within the field of tobacco control. Several lines of indirect evidence suggest that smokeless tobacco could promote smoking cessation, not undermine it. Epidemiological data from Europe have observed smokeless tobacco use to be associated with increased quitting. The only two randomized studies to report on prospective changes in smoking behavior (one from this lab) both suggest a potential benefit of smokeless tobacco to enhance quitting of cigarettes. If substantiated, this would have important clinical and policy implications, particularly for the majority of smokers who remain unwilling or unable to quit. To address this gap in the evidence, the investigators propose the largest (N=1,250) and longest (one year) RCT of oral, non-combustible tobacco (i.e., Camel Snus) as a means of cessation induction among smokers who are otherwise unmotivated to quit. A population-based, nationwide sample of smokers will be proactively recruited through established methods, consented to enroll in a telephone-based cessation induction trial, and randomized to either a) provision of Camel Snus, or b) not. The investigators have demonstrated previously the feasibility of this approach -- both to efficiently recruit and effectively retain large numbers of unmotivated smokers. Though a number of outcomes will be tracked, the investigators' primary aims are to examine 1) the impact of Snus use on smoking behavior (e.g., quit attempts, cessation, smoking reduction), 2) mediational mechanisms of this relationship, and 3) extent of uptake and usage of Camel Snus (including prevalence, amount, and patterns of use). It is critical to objectively assess the impact of PREPs on quit attempts before they reach wide popularity. This application is particularly well-timed given recent legislation that provides the FDA with regulatory authority over tobacco. The major significance of this study is its potential to clarify the population impact of a newly developed and aggressively marketed PREP, particularly for the majority of smokers who remain unmotivated to quit. The study will provide strong, clear, and objective evidence to guide clinical and regulatory decision-making for this controversial area of tobacco control.
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