A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction
A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction
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DOI：
10.1093/ntr/ntp054
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发表时间：
2009-06-01
影响因子：
4.7
通讯作者：
Whittaker, Robyn
中科院分区：
文献类型：
--
作者：
Thornley, Simon;McRobbie, Hayden;Whittaker, Robyn
我们比较了4毫克的尼古丁口服袋(Zonnic袋)、尼古丁口香糖和安慰剂袋对隔夜戒烟后戒断不适的影响。我们还评估了参与者的喜好、满意度和消费模式。这是一项对30名成年吸烟者进行的随机、安慰剂对照、三方交叉研究。在隔夜戒烟后，受试者在使用前和第一次使用产品后的第一个小时内报告了视觉模拟评分(VAS；0-100)烟草戒断症状(渴望、易怒、注意力难以集中和躁动)。然后，他们在整个研究白天使用该产品，并在晚上报告该产品的有效性、暂时戒断成功和满意度。在多变量分析中，尼古丁药袋组在服用研究药物60分钟后曲线下面积(渴望与时间)减少了23个百分点，而口香糖和安慰剂组分别减少了15个和8个百分点。袋子和安慰剂之间的渴望评级差异显著(p=0.002)。尼古丁袋子比口香糖更能减少刺激性(差异=9.86；p=0.01)。对于袋子使用者，研究期间暂时戒烟(21.5小时)(与口香糖相比)的优势比为2.8(95%CI=0.8-8.1)。与口香糖相比，口香糖被评为“有助于戒烟”(差异=20.6；95%CI=2.4-38.9)和“使用舒适”(差异=17.3；95%CI=2.6-32.0)。Zonnic口香糖似乎与尼古丁口香糖一样有效，而且主观上比口香糖更受青睐。这些结果表明，这种袋子将是现有尼古丁替代疗法范围内的有益补充。
We compared the effects of a 4-mg oral nicotine pouch (Zonnic pouch), with nicotine chewing gum and placebo pouch, on withdrawal discomfort after overnight tobacco abstinence. We also assessed participants' preferences, satisfaction, and consumption patterns.This was a randomized, placebo-controlled, three-way crossover study of 30 adult smokers. After overnight tobacco abstinence, subjects reported on a Visual Analog Scale (VAS; 0-100) tobacco withdrawal symptoms (craving, irritability, difficulty concentrating, and restlessness) before use and during the first hour after first product use. They then used the product throughout the study day and in the evening reported product usefulness, temporary abstinence success, and satisfaction.In a multivariate analysis, area under the curve (craving vs. time) was reduced by 23 points 60 min after taking the study medication in the nicotine pouch group, compared with 15- and 8-point decreases in the gum and placebo groups, respectively. The difference in craving ratings between the pouch and placebo was significant (p = .002). Nicotine pouch reduced irritability more than gum (difference = 9.86; p = .01). For pouch users, the odds ratio for temporary tobacco abstinence (21.5 hr) during study days (compared with gum) was 2.8 (95% CI = 0.8-8.1). Compared with the gum, the pouch was rated as significantly more "helpful to stop smoking" (difference = 20.6; 95% CI = 2.4-38.9) and "pleasant to use" (difference = 17.3; 95% CI = 2.6-32.0).The Zonnic pouch appears to be as effective at relieving craving as nicotine gum and was subjectively favored over the gum. These results suggest that the pouch will be a helpful addition to the range of existing nicotine replacement treatments.