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Randomized Controlled Trial
. 2009 Dec;11(12):1415-23.
doi: 10.1093/ntr/ntp154. Epub 2009 Oct 30.

A randomized clinical trial of nicotine lozenge for smokeless tobacco use

Jon O Ebbert  1 , Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R Schroeder
Affiliations
Randomized Controlled Trial

A randomized clinical trial of nicotine lozenge for smokeless tobacco use

Jon O Ebbert et al. Nicotine Tob Res. 2009 Dec.

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.

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Figures

Figure 1.
Figure 1.
CONSORT study flow diagram.
Figure 2.
Figure 2.
Prolonged abstinence from smokeless tobacco assessed using a time-to-event analysis with curves constructed using the Kaplan–Meier method (log rank p = .013).
See this image and copyright information in PMC

References

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