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Clinical Trial
. 2013 Dec;15(12):2037-44.
doi: 10.1093/ntr/ntt097. Epub 2013 Jul 19.

A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users

Jon O Ebbert  1 , Ivana T Croghan, Darrell R Schroeder, Richard D Hurt
Affiliations
Clinical Trial

A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users

Jon O Ebbert et al. Nicotine Tob Res. 2013 Dec.

Abstract

Introduction: Nicotine patch therapy has not been shown to be efficacious for increasing long-term (≥6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Higher doses of nicotine patch therapy may be needed to increase tobacco abstinence rates in this population of tobacco users.

Methods: We randomized ST users who used ≥3 cans/pouches per week to either 8 weeks of high-dose nicotine patch therapy (42mg/day) or matching placebo patch. Subjects were followed for 6 months after randomization.

Results: Fifty-two subjects were randomized. Compared with placebo, high-dose nicotine patch therapy was associated with significantly higher prolonged tobacco abstinence at end-of-treatment (44% vs. 22%, odds ratio [OR] = 2.7, p = .050) and 3 months (40% vs. 19%, OR = 2.9, p = .047). High-dose nicotine patch therapy was associated with significant weight gain attenuation among tobacco abstinence subjects at 3 months (p = .013) and 6 months (p = .018). Compared with placebo, high-dose nicotine patch therapy was associated with nonsignificantly lower nicotine withdrawal scores. Adverse events were not significantly increased with high-dose nicotine patch therapy.

Conclusions: High-dose nicotine patch therapy is safe and increases short-term tobacco abstinence rates among ST users who use ≥3 cans/pouches per week. High-dose nicotine patch therapy is associated with significant long-term attenuation of weight gain. Future studies to investigate the long-term efficacy of high-dose nicotine patch therapy and the comparative efficacy of this approach compared with standard nicotine patch doses for ST users seems warranted.

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Figures

Figure 1.
Figure 1.
CONSORT diagram.
Figure 2.
Figure 2.
Composite nicotine withdrawal of smokeless tobacco users in a randomized clinical trial of high-dose nicotine patch therapy.
See this image and copyright information in PMC

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