DESCRIPTION (provided by applicant): According to the 1999 National Household Survey on Drug Abuse, an estimated 7.6 million of the United States population 12 years of age and older (3.4%) currently use spit tobacco (ST). Long-term ST use increases the risk of developing oral leukoplakia, oropharyngeal cancer, and periodontal disease. Few studies of interventions for ST users have been conducted. A novel treatment approach for ST users employing existing pharmacotherapeutic agents is high dose nicotine patch therapy. Nicotine replacement therapy using standard dose nicotine patch therapy has not been shown to be effective for increasing tobacco abstinence rates in ST users. Our previous research in smokers shows that a high proportion of tobacco users have inadequate replacement of baseline serum nicotine levels with a standard nicotine patch dose and that higher doses (up to 44 mg/d) reduce nicotine withdrawal symptoms and increase tobacco abstinence rates. Since total daily nicotine exposure among ST users may be higher than in smokers, we propose that high dose nicotine patch therapy will improve withdrawal symptom relief, be safe and well-tolerated, increase tobacco abstinence rates and increase the replacement of baseline serum nicotine levels in ST users. To test these hypotheses, we will conduct a 3-phase study in which 60 adult ST users will be randomized to placebo or 3 different nicotine patch doses (21, 42, or 63 mg/d) with monitoring in our General Clinical Research Center (GCRC). Withdrawal symptom data will be collected using an Electronic Diary (ED). All subjects will receive a behavioral intervention during participation in the study. This ROl pilot study will serve as the foundation upon which the Principal Investigator will build a line of research committed to the health promotion and disease prevention objectives of Healthy People 2000. Our goal is to reduce the prevalence of ST use and decrease the incidence of oropharyngeal cancer through the development of effective treatment options for ST users.
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