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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA096881-01
Application #
6521672
Study Section
Special Emphasis Panel (ZRG1-RPHB-2 (01))
Program Officer
Backinger, Cathy L
Project Start
2002-07-15
Project End
2005-06-30
Budget Start
2002-07-15
Budget End
2003-06-30
Support Year
1
Fiscal Year
2002
Total Cost
$249,137
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
City
Rochester
State
MN
Country
United States
Zip Code
55905
Carr, Alan B; Ebbert, Jon (2012) Interventions for tobacco cessation in the dental setting. Cochrane Database Syst Rev :CD005084
Ebbert, Jon O; Post, Jason A; Moyer, Thomas P et al. (2007) Nicotine percentage replacement among smokeless tobacco users with nicotine patch. Drug Alcohol Depend 89:223-6
Ebbert, Jon O; Dale, Lowell C; Patten, Christi A et al. (2007) Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users. Nicotine Tob Res 9:43-52
Thomas, Janet L; Ebbert, Jon O; Patten, Christi A et al. (2006) Measuring nicotine dependence among smokeless tobacco users. Addict Behav 31:1511-21
Ebbert, Jon O; Patten, Christi A; Schroeder, Darrell R (2006) The Fagerstrom Test for Nicotine Dependence-Smokeless Tobacco (FTND-ST). Addict Behav 31:1716-21
Ebbert, Jon O; Klinkhammer, Martin D; Stevens, Susanna R et al. (2005) A survey of characteristics of smokeless tobacco users in a treatment program. Am J Health Behav 29:25-35
Ebbert, Jon O; Carr, Alan B; Dale, Lowell C (2004) Smokeless tobacco: an emerging addiction. Med Clin North Am 88:1593-605
Sood, Amit; Erwin, Patricia J; Ebbert, Jon O (2004) Using advanced search tools on PubMed for citation retrieval. Mayo Clin Proc 79:1295-9; quiz 1300
Ebbert, Jon O; Rowland, Leah C; Montori, Victor M et al. (2003) Treatments for spit tobacco use: a quantitative systematic review. Addiction 98:569-83
Ebbert, Jon O; Dupras, Denise M; Erwin, Patricia J (2003) Searching the medical literature using PubMed: a tutorial. Mayo Clin Proc 78:87-91