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

ABSTRACT

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 1–3, 4–7, and 8–14.

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.

Key words: :

• Craving
• Nicotine patch
• Nicotine replacement therapy
• Smoking cessation

* GlaxoSmithKline Consumer Healthcare

* GlaxoSmithKline Consumer Healthcare

Acknowledgements

Declaration of interest: These studies and analyses were sponsored by SmithKline Beecham, the corporate predecessor of GlaxoSmithKline Consumer Healthcare (GSKCH), Pittsburgh, PA, USA, which markets the 21 mg/24-h nicotine patch. S.S. designed and oversaw both studies. The analyses were conducted by the authors, who had full access to the data. The sponsor had no role in the preparation of the manuscript. The authors, through their work at PinneyAssociates, consult exclusively to GSKCH on matters related to smoking cessation. S.S. also has an interest in the development of a novel smoking cessation medication, and is a co-founder of invivodata, inc., which provides electronic diaries for clinical research. The authors acknowledge the contributions of Jean A. Paty, Duncan B. Clark, Celeste Elash, Stephanie M. Paton, and Kenneth Liu (all associated with the University of Pittsburgh at the time the data were collected there), who helped conduct the studies, and Gina Bittner, Pinney Associates, who assisted with the preparation of the manuscript.

Notes

* GlaxoSmithKline Consumer Healthcare