PDF(Pubmed)
Abstract：
Tobacco-free nicotine pouches are new nicotine products for oral consumption. They can contain very high nicotine amounts that have not been addressed with clinical studies yet. Thus, nicotine delivery, effects on craving, and side effects were assessed using pouches with up to 30 mg nicotine. In this single-center, five-arm, crossover study, 15 regular cigarette smokers consumed tobacco-free nicotine pouches from different brands with 6, 20, and 30 mg for 20 min. Comparators were nicotine-free pouches and tobacco cigarettes. At baseline and predefined time points over a study period of 240 min, plasma nicotine concentrations, effects on cigarette craving, and side effects were assessed. Cardiovascular parameters including arterial stiffness were measured using a MobilOGraph. Consumption of 30 mg nicotine pouches has led to a higher nicotine uptake compared with the cigarette (Cmax: 29.4 vs 15.2 ng/mL; AUC: 45.7 vs 22.1 ng/mL × h). Nicotine uptake in the acute phase was rapid during use of the 30 mg pouch and cigarette. Extraction rate of nicotine differed between pouches. Use of all products has reduced acute cigarette craving, even the nicotine-free pouch. During consumption of the cigarette and the pouches with 20 and 30 mg, heart rate increased about 27, 12, and 25 bpm, respectively. Parameters for arterial stiffness were elevated and all pouches have induced mouth irritations. The pouches with 30 mg nicotine had overall the strongest side effects and may induce addiction. As craving was also reduced by products with less nicotine, it is questionable whether such high nicotine contents should be allowed on the market. A limit of nicotine content is warranted. The nicotine release rate varies across products and needs to be known to estimate the nicotine delivery.
摘要：
无烟草尼古丁袋是用于口服消费的新型尼古丁产品。它们可能含有非常高的尼古丁量，临床研究尚未解决。因此，尼古丁输送，对渴望的影响，和副作用使用含30毫克尼古丁的小袋进行评估。在这个单一中心，五臂，交叉研究，15名常规吸烟者使用6、20和30mg的不同品牌的无烟草尼古丁袋20分钟。比较物是不含尼古丁的小袋和烟草香烟。在240分钟研究期间的基线和预定时间点，血浆尼古丁浓度，对香烟渴望的影响，和副作用进行了评估。使用MobilOGraph测量包括动脉硬度的心血管参数。与香烟相比，消耗30mg尼古丁袋导致更高的尼古丁摄取（Cmax：29.4vs15.2ng/mL；AUC：45.7vs22.1ng/mL×h）。在使用30mg小袋和香烟期间，急性期的尼古丁吸收迅速。尼古丁的提取率在小袋之间有所不同。所有产品的使用都减少了对香烟的急性渴望，甚至是不含尼古丁的袋子.在消费香烟和20和30毫克的袋子期间，心率增加了大约27、12和25bpm，分别。动脉僵硬度的参数升高，所有小袋都会引起口腔刺激。具有30mg尼古丁的小袋总体上具有最强的副作用并且可能诱导成瘾。由于尼古丁含量较低的产品也减少了渴望，如此高的尼古丁含量是否应该允许在市场上出售是值得怀疑的。尼古丁含量的限制是必要的。尼古丁释放速率因产品而异,并且需要已知以估计尼古丁递送。
