Abstract
BackgroundAbility to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Thus, this study was performed to compare relief of urges to smoke, up until 5 h following treatment with a new 6 mg nicotine gum versus currently marketed 4 mg nicotine gum.MethodsThis was a randomized crossover clinical study. Following 12 h of abstinence from smoking, either one 6 mg or one 4 mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100 mm Visual Analogue Scale repeatedly over 5 h.ResultsThe reductions in urges to smoke over the first 1 and 3 h after administration were statistically significantly greater with 6 mg than 4 mg gum, (p < 0.005). A 50% reduction in perceived urges to smoke was reached in 9.4 min with 6 mg gum compared to 16.2 min with 4 mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111 min with the 6 mg gum, versus 74 min for the 4 mg gum.ConclusionThis study provides evidence that the 6 mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4 mg nicotine gum.Trial registrationEudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.
Highlights
Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation
A 50% reduction in perceived urges to smoke was estimated to be reached in 9.4 min with 6 mg gum compared to 16.3 min with 4 mg gum (p-value for the null hypothesis of equal time-to-event distributions 0.001)
We found that the 6 mg gum provided statistically significantly greater relief of urges to smoke than 4 mg gum within intervals up to 3, 5, 10 min, 1, 2, 3, 4 and 5 h after start of administration, i.e. 6 mg gums provide a greater craving relief than 4 mg gums in a population of smokers who were highly dependent
Summary
Ability to manage urges to smoke is fundamental to maximizing the chances of success in smoking cessation. Previous studies have linked a higher dose of nicotine in nicotine replacement therapy to a higher success rate for smoking cessation. Three studies have investigated the hypothesis that craving is the mechanism through which pharmacological treatment has an effect on smoking cessation and found evidence of partial mediation [5,6,7]. Management of cravings is fundamental to maximizing the chances of success in a quit attempt. Relief of cravings and withdrawal symptoms represents the primary intended use of nicotine replacement therapy (NRT) and relief of these symptoms is the principal mechanism of action of NRT in the support of smoking cessation [8]. NRT increases the success rate of attempts to quit smoking by approximately 50% versus placebo [9, 10], long-term success rates are low [11]
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