Skip Navigation



Nicotine & Tobacco Research Advance Access published online on October 30, 2009
Nicotine & Tobacco Research, doi:10.1093/ntr/ntp154
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Article Summary
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Ebbert, J. O.
Right arrow Articles by Schroeder, D. R.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Ebbert, J. O.
Right arrow Articles by Schroeder, D. R.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© The Author 2009. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

A randomized clinical trial of nicotine lozenge for smokeless tobacco use

Jon O. Ebbert, Herbert H. Severson, Ivana T. Croghan, Brian G. Danaher and Darrell R. Schroeder

Jon O. Ebbert, M.D., M.S., Mayo Clinic College of Medicine, Rochester, MN
Herbert H. Severson, Ph.D., Oregon Research Institute, Eugene
Ivana T. Croghan, Ph.D., Mayo Clinic College of Medicine, Rochester, MN
Brian G. Danaher, Ph.D., Oregon Research Institute, Eugene
Darrell R. Schroeder, M.S., Mayo Clinic College of Medicine, Rochester, MN

Corresponding Author: Jon O. Ebbert, M.D., M.S., Mayo Clinic College of Medicine; 200 1st Street Southwest, Rochester, MN 55905, USA. Telephone: 507-266-1944; Fax: 507-266-7900; E-mail: ebbert.jon{at}mayo.edu


  Abstract

Introduction: Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users.

Methods: We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use.

Results: We randomized 270 participants (136 active lozenge, 134 placebo). No significant differences were observed between the groups in biochemically confirmed all tobacco abstinence rates at Week 12 (36% lozenge vs. 27.6% placebo; odds ratio [OR] 1.5, 95% CI 0.7–2.1; p = .138). However, the 4-mg nicotine lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2–3.2; p = .011) and self-reported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2–3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased significantly with time (time effect = –.022 per day, SE = .003; p < .001) and was significantly lower for the active lozenge (treatment effect = –.213, SE = .071; p = .003). Tobacco craving also decreased significantly following TQD (time effect = –.071, SE = .006; p < .001) and was lower for the active nicotine lozenge (treatment effect = –.452, SE = .164; p = .006).

Discussion: The 4-mg nicotine lozenge increased self-reported but not biochemically confirmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.

Received: May 19, 2009; Accepted: August 21, 2009
Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.