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The effect of a nicotine patch on cigarette craving over the course of the day: Results from two randomized clinical trials


Shiffman, S and Ferguson, SG, The effect of a nicotine patch on cigarette craving over the course of the day: Results from two randomized clinical trials, Current Medical Research and Opinion, 24, (10) pp. 2795-2804. ISSN 0300-7995 (2008) [Refereed Article]

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Copyright Statement

Copyright 2008 Informa Plc.

DOI: doi:10.1185/03007990802380341


Objectives: The objective of this analysis was to assess the efficacy of a 21 mg/24-h nicotine patch for the reduction of craving throughout the waking day, compared both to placebo, and to a 15 mg/16-h patch differing pharmacokinetic profile over the day. The primary end-point was craving during the evening hours, because previous research suggested that smoking relapse was particularly likely at that time. Research design and methods: Data were drawn from two similar randomized clinical trials among nicotine-dependent smokers who were quitting smoking: Study 1 compared the 21 mg/24-h patch to a placebo patch, while Study 2 compared the 21 mg/24-h patch to a 15 mg/16-h nicotine patch. In both studies, subjects (Study 1: n = 102; Study 2: n = 244) were prompted by an electronic diary to rate their craving multiple times per day during a 1 week baseline period, and for up to 2 weeks after quitting. For analysis, the day was divided into five blocks: morning (up to 10:59 a.m.), mid-day (11:00 a.m.1:59 p.m.), afternoon (2:00 p.m.4:59 p.m.), evening (5:00 p.m.8:59 p.m.), and late night (9:00 p.m. onwards). The individual craving ratings were divided into three intervals based on time since quitting: Days 13, 47, and 814. Results: The 21 mg/24-h nicotine patch resulted in significantly lower craving during all post-quit intervals, at each time of day, both compared to placebo (Study 1), and compared to the 15 mg/16-h nicotine patch (Study 2). Study 2 saw a significant treatment by interval interaction: in later time intervals, the difference in craving experience between 24- and 16-h patch conditions shrunk while remaining significantly different as overall levels of craving experienced by subjects in the two groups dropped. Adverse events reported in both studies tended to be mild and transient, consistent with the well characterized adverse event profile of nicotine patches. Conclusions: Study 1 demonstrated that a 21 mg/24-h patch was effective in reducing craving throughout the day, including the evening period when relapse risk is heightened. A further study comparing the 21 mg/24-h patch to a 15 mg/16-h nicotine patch found that craving was significantly lower at all times of day for smokers using the 21 mg/24-h patch. The studies were limited in that craving was only monitored for the first 2 weeks of quitting (when craving is most prominent), and cannot elucidate the impact of patch use on craving outside of this time. Also, there was substantial attrition of the sample over time, partly due to relapse in all conditions.

Item Details

Item Type:Refereed Article
Keywords:Craving, Nicotine patch, Nicotine replacement therapy, Smoking cessation
Research Division:Health Sciences
Research Group:Public health
Research Field:Preventative health care
Objective Division:Health
Objective Group:Public health (excl. specific population health)
Objective Field:Public health (excl. specific population health) not elsewhere classified
UTAS Author:Ferguson, SG (Professor Stuart Ferguson)
ID Code:57255
Year Published:2008
Web of Science® Times Cited:24
Deposited By:Pharmacy
Deposited On:2009-07-01
Last Modified:2011-07-25

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