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

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.

Figures

Figure 1.

CONSORT diagram.

Figure 2.

Composite nicotine withdrawal of smokeless tobacco users in a randomized clinical trial of high-dose nicotine patch therapy.