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. 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. This 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. The 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. This 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. EudraCT Number: 2010–023268-42. Study was first entered in EudraCT 2011-02-23.

中文翻译：

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尼古丁 6 毫克口香糖对吸烟冲动的影响，一项随机临床试验

控制吸烟冲动的能力对于最大限度地提高戒烟成功机会至关重要。先前的研究已将尼古丁替代疗法中较高剂量的尼古丁与较高的戒烟成功率联系起来。因此，本研究旨在比较新的 6 毫克尼古丁口香糖与目前市售的 4 毫克尼古丁口香糖治疗后 5 小时内吸烟冲动的缓解情况。这是一项随机交叉临床研究。戒烟 12 小时后，240 名健康成年吸烟者服用了 1 颗 6 毫克或一颗 4 毫克尼古丁口香糖。此后，在 5 小时内用 100 mm 视觉模拟量表反复对吸烟冲动进行评分。服用 6 毫克口香糖比服用 4 毫克口香糖在给药后 1 小时和 3 小时内对吸烟冲动的减少具有统计学意义（p < 0.005）。与 4 毫克口香糖 16.2 分钟相比，6 毫克口香糖在 9.4 分钟内感知到的吸烟冲动减少了 50%（中位值）。6 毫克口香糖使 VAS 吸烟冲动评分降低 50% 或更多的中位持续时间为 111 分钟，而 4 毫克口香糖为 74 分钟。这项研究提供的证据表明，与 4 毫克尼古丁口香糖相比，6 毫克尼古丁口香糖可以更大、更快、更长时间地缓解吸烟冲动。EudraCT 编号：2010–023268-42。研究首次进入 EudraCT 2011-02-23。