Elsevier

Clinical Therapeutics

Volume 30, Issue 10, October 2008, Pages 1852-1858
Clinical Therapeutics

Relationship between adherence to daily nicotine patch use and treatment efficacy: Secondary analysis of a 10 week randomized, double-blind, placebo-controlled clinical trial simulating over-the-counter use in adult smokers

https://doi.org/10.1016/j.clinthera.2008.09.016Get rights and content

Abstract

Background: It has been reported that the efficacy of acute forms of nicotine replacement therapy, such as nicotine gum and lozenges, improves when sufficient quantities of medication are used.

Objective: This analysis examined whether adherence with daily nicotine patch wear was associated with improved rates of smoking abstinence.

Methods: This was a secondary analysis of data from a double-blind study in which subjects were randomized to receive either an active nicotine patch or a placebo patch under simulated over-the-counter conditions. Subjects were asked to complete a daily diary on their patch use and smoking. Logistic regression, controlling for smoking in the first 3 weeks of treatment, was used to evaluate the likelihood of abstinence at 6 weeks as a function of treatment assignment (active vs placebo) and adherence (ie, patch wear for ≥20 of the first 21 days of treatment). The relationship between reported adverse events and adherence was also examined.

Results: This analysis involved data from 371 subjects, 204 using the active patch and 167 using the placebo patch. The study population was mainly white (87.3%), had a mean age of 42.8 years, a mean weight of 77.3 kg, had been smoking for a mean of 24.4 years, and smoked a mean of 25.2 cigarettes per day. Two hundred fifty-three subjects were classified as adherent. Rates of adherence did not differ significantly between the active and placebo groups (139 [68.1%] and 114 [68.3%], respectively). The likelihood of experiencing an adverse event did not differ significantly between adherent and nonadherent subjects in either group. Among active patch users, 61.5% of nonadherent subjects experienced an adverse event, compared with 59.7% of adherent subjects; among placebo patch users, the corresponding proportions were 41.5% and 43.9%. Among active patch users, the odds of abstinence at 6 weeks were more than 3 times greater for adherent versus nonadherent subjects (53.2% vs 21.5%, respectively; adjusted odds ratio [OR] = 3.25; 95% CI, 1.30-8.09; P = 0.011); no benefit of adherence over nonadherence was seen among users of the placebo patch (16.7% vs 15.1%; adjusted OR = 0.60; 95% CI, 0.16-2.31). The interaction between treatment group and adherence was statistically significant (P = 0.022).

Conclusion: Under conditions simulating over-thecounter use, adherence to daily nicotine patch wear within the first 3 weeks of treatment was associated with an improved likelihood of achieving smoking abstinence at 6 weeks.

References (22)

  • PH Jackson et al.

    Nicotine gum use and outcome in a general practitioner intervention against smoking

    Addict Behav

    (1989)
  • P Tønnesen et al.

    A double-blind trial of a nicotine inhaler for smoking cessation

    JAMA

    (1993)
  • LF Stead et al.

    Nicotine replacement therapy for smoking cessation

    Cochrane Database Syst Rev

    (2008)
  • Nicorette nicotine polacrilex gum 2mg and 4mg [FDA...
  • Commit nicotine polacrilex lozenge 2mg and 4mg [FDA Web...
  • S Shiffman et al.

    The efficacy of computer-tailored smoking cessation materials as a supplement to nicotine polacrilex gum therapy

    Arch Intern Med

    (2000)
  • EK Burns et al.

    Discontinuation of nicotine replacement therapy among smoking-cessation attempters

    Am J Prev Med

    (2008)
  • NicoDerm CQ 21 mg nicotine patch [FDA Web...
  • S Shiffman et al.

    Patterns of overthe-counter nicotine gum use: Persistent use and concurrent smoking

    Addiction

    (2003)
  • S Shiffman et al.

    Persistent use of nicotine replacement therapy: An analysis of actual purchase patterns in a population based sample

    Tob Control

    (2003)
  • ED Glover et al.

    Smoking cessation in highly dependent smokers with 4mg nicotine polacrilex

    Am J Health Behav

    (1996)
  • Cited by (80)

    • Predictors of adherence to nicotine replacement therapy: Machine learning evidence that perceived need predicts medication use

      2019, Drug and Alcohol Dependence
      Citation Excerpt :

      Nonadherence to smoking cessation medication is common amongst people trying to quit smoking (Mooney et al., 2005; Shiffman et al., 2008).

    View all citing articles on Scopus

    These data were presented as a poster at the 13th Annual Meeting of the Society for Research on Nicotine and Tobacco, February 21-27, 2007, Orlando, Florida.

    View full text