Chest
Volume 105, Issue 2, February 1994, Pages 524-533
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Clinical Investigations
Miscellaneous
Two Studies of the Clinical Effectiveness of the Nicotine Patch With Different Counseling Treatments

https://doi.org/10.1378/chest.105.2.524Get rights and content

Objective

To assess the effectiveness of transdermal nicotine therapy for smoking cessation and suppression of withdrawal severity in conjunction with two different adjuvant counseling treatments.

Design

Two independent randomized placebo-controlled double-blind trials.

Setting

Smoking cessation clinic.

Subjects

Eighty-eight (study 1) and 112 (study 2) adult volunteers motivated to quit smoking.

Interventions

Eight weeks of 22-mg transdermal nicotine therapy with group conseling (study 1); 4 weeks of 22 mg followed by 2 weeks of 11-mg transdermal nicotine therapy with brief individual counseling (study 2).

Main outcome measures

Modified point prevalence (7 consecutive days of nonsmoking) at the end of patch treatment and 6 months after treatment initiation was assessed by self-report and biochemically confirmed; survival analyses were also conducted for both studies to compare treatment efficacy. Also, we examined the impact of the nicotine patch on specific withdrawal symptoms (anger, anxiety, awakening, difficulty concentrating, depression, hunger, impatience, and craving).

Results

Transdermal nicotine treatment produced higher cessation rates at the end of treatment than did placebo with both adjuvant counseling interventions: 59 percent vs 40 percent (p < 0.05 in study 1) and 37 percent vs 20 percent (p < 0.05 in study 2), respectively. Smoking cessation efficacy was maintained 6 months after initiation of treatment: 34 percent vs 21 percent (p = 0.08 in study 1) and 18 percent vs 7 percent (p = 0.05 in study 2). Survival analyses also revealed significant group differences in efficacy in both studies. Nicotine patches also suppressed a variety of withdrawal symptoms, including craving in the first weeks after patients quit smoking.

Conclusion

Transdermal nicotine effectively augments smoking cessation rates with two different types of counseling treatment. Overall, the nicotine patch approximately doubles the sustained rate of smoking cessation. Additionally, the nicotine patch provides relief from some tobacco withdrawal symptoms.

Section snippets

Methods

Two studies were conducted sequentially to assess the efficacy of nicotine patch therapy with different adjuvant counseling approaches. Subjects were recruited independently for the two studies, and were unaware of the type of adjuvant treatment to be used. In study 1, patch therapy was paired with group counseling. In study 2, the nicotine patch was paired with brief individual counseling. The methods used in both studies were similar except as noted below.

Study 1

Table 1 depicts the baseline characteristics of subjects in the active and placebo groups. No statistically significant differences between the two groups were obtained. Of the 88 subjects who were enrolled and randomized, 77 completed the cessation treatment phase (ie, wore patches as directed for 8 weeks) of the study. Of the 11 who failed to complete the cessation treatment phase (first 8 weeks on study), 10 had placebo patches and 1 had active treatment.

Efficacy

End of Treatment: At the end of patch

Discussion

Along with a growing body of research,6,8, 9, 10, 11, 12,20, 21, 22 these studies show that the nicotine patch is very effective in increasing the rates of both short-term and long-term smoking abstinence among individuals motivated to quit. In both study 1 and 2, point prevalence and survival analyses demonstrated that patients wearing the nicotine patch were more successful in quitting smoking. Moreover, this research adds to the literature by demonstrating that the nicotine patch is

References (24)

  • SC Mulligan et al.

    Clinical and pharmacokinetic properties of a transdermal nicotine patch

    Clin Pharmacol Ther

    (1990)
  • T Abelin et al.

    Effectiveness of a transdermal nicotine system in smoking cessation studies

    Methods Find Exp Clin Pharmacol

    (1989)
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    This study was supported by a research grant provided by Elan Pharmaceutical Research Corporation, Gainesville, Ga, and Athlone, Ireland.

    revision accepted June 30.

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