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Grant Details

Grant Number: 5R01CA096881-03 Interpret this number
Primary Investigator: Ebbert, Jon
Organization: Mayo Clinic Rochester
Project Title: High Dose Nicotine Patch Therapy for Spit Tobacco Users
Fiscal Year: 2004
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Abstract

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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Publications

Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users.
Authors: Ebbert JO, Dale LC, Patten CA, Croghan IT, Schroeder DR, Moyer TP, Hurt RD
Source: Nicotine Tob Res, 2007 Jan;9(1), p. 43-52.
PMID: 17365735
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The Fagerström Test for Nicotine Dependence-Smokeless Tobacco (FTND-ST).
Authors: Ebbert JO, Patten CA, Schroeder DR
Source: Addict Behav, 2006 Sep;31(9), p. 1716-21.
EPub date: 2006 Jan 31.
PMID: 16448783
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A survey of characteristics of smokeless tobacco users in a treatment program.
Authors: Ebbert JO, Klinkhammer MD, Stevens SR, Rowland LC, Offord KP, Ames SC, Dale LC
Source: Am J Health Behav, 2005 Jan-Feb;29(1), p. 25-35.
PMID: 15604048
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Using advanced search tools on PubMed for citation retrieval.
Authors: Sood A, Erwin PJ, Ebbert JO
Source: Mayo Clin Proc, 2004 Oct;79(10), p. 1295-9; quiz 1300.
PMID: 15473412
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Smokeless tobacco: an emerging addiction.
Authors: Ebbert JO, Carr AB, Dale LC
Source: Med Clin North Am, 2004 Nov;88(6), p. 1593-605.
PMID: 15464115
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Treatments for spit tobacco use: a quantitative systematic review.
Authors: Ebbert JO, Rowland LC, Montori VM, Vickers KS, Erwin PJ, Dale LC
Source: Addiction, 2003 May;98(5), p. 569-83.
PMID: 12751971
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Searching the medical literature using PubMed: a tutorial.
Authors: Ebbert JO, Dupras DM, Erwin PJ
Source: Mayo Clin Proc, 2003 Jan;78(1), p. 87-91.
PMID: 12528881
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