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Grant Details

Grant Number: 5R01CA096881-03 Interpret this number
Primary Investigator: Ebbert, Jon
Organization: Mayo Clinic
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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA96881

MeSH Terms:
Questionnaires Skin Substance Withdrawal Syndrome
Dose-Response Relationship, Drug Humans Tobacco Use Disorder
Pilot Projects Tobacco, Smokeless Nicotine
Adult Tobacco Use Cessation Administration, Topical
Female Male

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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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA096881-03 NCI NIH HHS - R01 CA096881-01 NCI NIH HHS - R01 CA096881-02
NCRR NIH HHS - M01 RR000585 NCI NIH HHS - R01 CA96881

MeSH Terms:
Psychiatric Status Rating Scales Cotinine Reproducibility of Results
Double-Blind Method Nicotine Tobacco Use Disorder
Humans Adult Middle Aged
Psychometrics Biological Markers Tobacco, Smokeless

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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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA96881 NCI NIH HHS - R25 CA86421

MeSH Terms:
Questionnaires Telephone Tobacco Use Disorder
Humans Aged Tobacco, Smokeless
Cross-Sectional Studies Aged, 80 and over Family Therapy
Adult Follow-Up Studies Middle Aged
Social Support Adolescent Tobacco Use Cessation
Female Male

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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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA96881-01

MeSH Terms:
Medical Informatics Information Storage and Retrieval PubMed

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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
Related Citations

Grant Numbers:
NCI NIH HHS - CA90884 NCI NIH HHS - CA96881

MeSH Terms:
United States Mouth Diseases Tobacco Use Disorder
Humans Tobacco Use Cessation Tobacco, Smokeless

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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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA96881 NCI NIH HHS - R25 CA86421

MeSH Terms:
United States Randomized Controlled Trials as Topic Nicotine
Tobacco Use Disorder Humans Chewing Gum
Bupropion Treatment Outcome Ganglionic Stimulants
Tobacco, Smokeless

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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
Related Citations

Grant Numbers:
NCI NIH HHS - R01 CA96881-01

MeSH Terms:
Clinical Competence Humans Physicians
Terminology as Topic PubMed

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