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.

• Authors: Jon O Ebbert, Ivana T Croghan, Darrell R Schroeder, Richard D Hurt
• Journal: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco (Nicotine Tob Res) Vol. 15 Issue 12 Pg. 2037-44 (Dec 2013) ISSN: 1469-994X [Electronic] England
• PMID: 23873976 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Nicotine

Topics

• Adolescent
• Adult
• Behavior Therapy (methods)
• Dose-Response Relationship, Drug
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Nicotine (administration & dosage)
• Smoking (drug therapy)
• Smoking Cessation (methods)
• Substance Withdrawal Syndrome (drug therapy)
• Tobacco Use Cessation Devices
• Tobacco Use Disorder (drug therapy)
• Tobacco, Smokeless (statistics & numerical data)
• Treatment Outcome
• Weight Gain
• Young Adult