Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy: A randomized, placebo-controlled, double-blind study

University of Nebraska Medical Center, Department of Internal Medicine, Omaha 68198-2465.
Archives of Internal Medicine (Impact Factor: 17.33). 05/1991; 151(4):749-52. DOI: 10.1001/archinte.151.4.749
Source: PubMed


To assess the smoking cessation efficacy of transdermal nicotine patches as an adjunct to low-intervention therapy, we conducted a double-blind, placebo-controlled trial in 158 smokers. Participants were randomly assigned to one of the following three study regimens that required daily application of two 15-cm2 patches: (1) 24-hour nicotine delivery, (2) nicotine delivery during wakeful hours only, and (3) placebo. The impact of the three regimens on smoking cessation rates and tobacco withdrawal symptoms was examined. During the last 2 weeks of the trial, 39% of the 24-hour nicotine regimen delivery group, 35% of those on wakeful hour nicotine regimens, and 13.5% of the placebo treatment group achieved abstinence. Self-reported quit rates for the two nicotine patch-wearing regimens, as compared with that for the placebo group, continued to be significantly higher at 6 months. Moreover, compared with placebo, the transdermal nicotine patches significantly reduced tobacco withdrawal symptoms during the first few weeks of quitting. The differences in quit rates and tobacco withdrawal symptoms between the two active groups were not statistically significant. The patches were well tolerated both topically and systemically. We concluded that transdermal nicotine, when used as an adjunct to low-intervention therapy, significantly reduced tobacco withdrawal symptoms and enhanced smoking cessation rates.

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    • "Third, if withdrawal and craving result from lowered nicotine levels in the brain, we would expect that nicotine made available by Nicotine Replacement Therapies (NRT's) would be completely abolish withdrawal symptoms and craving. Although partial reduction of withdrawal symptoms was reported [73-75] we are not aware of a single study where all withdrawal symptoms and craving were suppressed by nicotine. The partial reduction in withdrawal achieved by NRT could well be the result of the inadequacy of the placebo controls used in the majority, if not all, of these studies. "
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    ABSTRACT: The reports of US Surgeon General on smoking are considered the authoritative statement on the scientific state of the art in this field. The previous report on nicotine addiction published in 1988 is one of the most cited references in scientific articles on smoking and often the only citation provided for specific statements of facts regarding nicotine addiction. In this commentary we review the chapter on nicotine addiction presented in the recent report of the Surgeon General. We show that the nicotine addiction model presented in this chapter, which closely resembles its 22 years old predecessor, could only be sustained by systematically ignoring all contradictory evidence. As a result, the present SG's chapter on nicotine addiction, which purportedly "documents how nicotine compares with heroin and cocaine in its hold on users and its effects on the brain," is remarkably biased and misleading.
    Harm Reduction Journal 05/2011; 8:12. DOI:10.1186/1477-7517-8-12 · 1.26 Impact Factor
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    • "Each visit included a few min of cessation advice and patch explanations Trials uncertainly classified Areechon and Punnotok, 1988 First visit included a lecture on the benefits of cessation of an unspecified duration. Weekly consultations with physician, unspecified content, duration and number Daughton et al,* 1991 "

    Tobacco control 07/2007; 16(3):215-6; author reply 216. · 5.93 Impact Factor
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    • "Given that early morning smoking urges may be a significant predictor of smoking relapse (Killen & Fortmann, 1997; Shiffman et al., 1997), better relief of morning smoking urges with 24-hr nicotine patches may lead to improved control of smoking abstinence. Indeed, Shiffman et al. (1997) reported a higher rate of abstinence with a 24-hr patch than with a 16-hr patch; however, this finding was not replicated in another study (Daughton et al., 1991) and by metaanalyses (Silagy et al., 2004). "
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    ABSTRACT: This randomized, open-label, crossover study was conducted to compare the effects of a 24-hr nicotine patch and a 16-hr nicotine patch on morning smoking urges and sleep quality of dependent smokers during a short period of cigarette abstinence. A total of 20 smokers (9 women and 11 men) smoking at least 20 cigarettes/day completed the two smoke-free study periods. For each period, cigarette abstinence started on the first evening and a nicotine patch was applied the next morning (for 16 or 24 hr), after baseline measures; a second patch was applied the next morning, 1 hr before the end of the experimental period. Smoking urges, mood and behavior self-reports, psychomotor performance, and polysomnographic recordings were compared between the two types of nicotine patch according to changes from baseline. Both patches decreased morning smoking urges, although results were significantly superior for the 24-hr patch. Furthermore, the 24-hr patch was more effective than the 16-hr patch in reducing the positive reinforcing dimension of smoking urges. Regarding polysomnographic recordings, the proportion of slow wave sleep was significantly increased from baseline with the 24-hr patch compared with the 16-hr patch. As for psychomotor performance measured through the critical flicker fusion test, significant improvement in morning alertness was observed in the 24-hr patch group. In conclusion, the 24-hr nicotine patch formulation is more effective than the 16-hr formulation in alleviating morning smoking urges and more specifically the positive reinforcing factor. The present findings do not support the idea that nicotine delivery during bedtime might disturb sleep, but rather it improves restorative sleep and postwaking arousal.
    Nicotine & Tobacco Research 05/2006; 8(2):193-201. DOI:10.1080/14622200500489989 · 3.30 Impact Factor
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