Effect of nicotine 6\u2009mg gum on urges to smoke, a randomized clinical trial

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\u2009h following treatment with a new 6\u2009mg nicotine gum versus currently marketed 4\u2009mg nicotine gum.MethodsThis was a randomized crossover clinical study. Following 12\u2009h of abstinence from smoking, either one 6\u2009mg or one 4\u2009mg nicotine gum was given to 240 healthy adult smokers. Thereafter, urges to smoke were scored on a 100\u2009mm Visual Analogue Scale repeatedly over 5\u2009h.ResultsThe reductions in urges to smoke over the first 1 and 3\u2009h after administration were statistically significantly greater with 6\u2009mg than 4\u2009mg gum, (p\u2009<\u20090.005). A 50% reduction in perceived urges to smoke was reached in 9.4\u2009min with 6\u2009mg gum compared to 16.2\u2009min with 4\u2009mg gum (median values). The median duration of a 50% or more reduction in VAS urges to smoke score was 111\u2009min with the 6\u2009mg gum, versus 74\u2009min for the 4\u2009mg gum.ConclusionThis study provides evidence that the 6\u2009mg nicotine gum provided a greater reduction, faster and longer relief of urges to smoke than the 4\u2009mg nicotine gum.Trial registrationEudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.