Although a significant number of smokeless tobacco (ST) users recognize the importance of quitting, many do not want to quit in the immediate future or perceive themselves as unable to quit. For these individuals, no intermediate or alternative treatment approaches have been studied. Tobacco reduction may be an important transitional goal for these individuals prior to becoming abstinent or even as a treatment endpoint. This 5-year grant proposal will examine whether effective approaches are available that can reduce the level of ST use as well as toxicity and facilitate cessation in those ST users unwilling or unable to quit ST use. Four studies are proposed. The first three studies will examine the efficacy of various strategies to reduce tobacco use and toxicity. These strategies involve: 1) reducing the level of nicotine while retaining sensory aspects and frequency of use; and 2) maintaining nicotine levels while reducing the frequency of use. ST users will be required to reduce their intake by 50 percent and then by 75 percent over an eight-week period. Subjects will then be followed at 12 and 26 weeks after the initiation of treatment. The first study will examine switching to a lower nicotine-containing ST product. The second and third studies will examine the effects of substituting tobacco free snuff and nicotine gum, respectively, for ST dips. The primary outcome measures across all studies include: the percent reduction in use; toxicity profile, e.g., NNK (4- [methylnitrosamino]-1-[3-pyridyl]-1-butanon) metabolites; the number who make greater than or equal to 24 hour quit attempts; and percent who achieve abstinence. The fourth study will examine whether a tobacco reduction strategy would be detrimental to cessation attempts. Subjects will be randomly assigned to usual care that emphasizes abstinence compared to a tobacco reduction strategy. In the tobacco reduction group, subjects will be required to reduce by at least 50 percent. The primary outcome variables are the percent who attained abstinence, time to drop-out and among those who were not able to quit, percent reduction in use. These studies will determine whether reduction approaches are effective in decreasing levels of exposure to tobacco and toxicity, as well as enhancing motivation to quit and number of quit attempts. In addition, this proposal will determine whether recommending a tobacco reduction strategy among ST users, unable or unwilling to quit, will facilitate or deter abstinence from use compared to an abstinence treatment approach. The results of this study will determine the potential for an alternative and viable method for treating ST users.
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