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

Jon O. Ebbert, Ivana T. Croghan, Darrell R. Schroeder, Richard D. Hurt

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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 (42 mg/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, highdose 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.

Original languageEnglish (US)
Pages (from-to)2037-2044
Number of pages8
JournalNicotine and Tobacco Research
Volume15
Issue number12
DOIs
StatePublished - Dec 2013

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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