Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.
Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.
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新型速效舌下含尼古丁片作为香烟替代策略。
DOI：
10.1007/s00213-022-06171-z
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发表时间：
2022
影响因子：
3.4
通讯作者：
McCarty,John
中科院分区：
文献类型：
--
作者：
Rose,JedE;Behm,FrederiqueM;Botts,TanaiaL;Botts,DavidR;Willette,PerryN;Vocci,Frank;McCarty,John
尼古丁目前的尼古丁替代产品提供比香烟慢得多的尼古丁释放开始，因此在取代吸烟方面仅略微有效。因此，更有效的形式的尼古丁replacement.ObjectivesThis初步调查的特点是一种新的舌下（SL）尼古丁片剂的药代动力学（PK）和主观效果，旨在提供尼古丁更迅速地到血流的smokers.MethodsStudy 1（N= 6）的特点是2毫克尼古丁SL片剂的药代动力学相比，FDA批准的，上市的2毫克尼古丁含片。研究2（N= 24）评估了吸烟者对单次使用1 mg和2 mg SL片剂的主观反应。结果研究1发现，SL片剂达到最大血液尼古丁浓度的时间（14 min）明显短于锭剂（82 min），尼古丁吸收的初始速率较高（0.4 ng/mL*min vs. 0.0 ng/mL*min），支持SL片剂更快速递送尼古丁的假设。研究2发现，参与者报告在服用片剂后尼古丁戒断症状立即缓解，并且在2 mg片剂接近其常用香烟品牌报告的程度后渴望减少（7分量表上为4.2 vs. 4.6）。其他的主观反应表明，片剂是一个有吸引力的替代smoking.ConclusionsThe新SL片剂研究表明，作为烟草危害减少和戒烟治疗的尼古丁替代策略的承诺。需要进行更多的研究来进一步研究这种新方法的潜力。
RationaleCurrent nicotine replacement products provide a much slower onset of nicotine delivery than cigarettes, and hence are only marginally effective at supplanting cigarette smoking. Therefore, more effective forms of nicotine replacement are needed.ObjectivesThis initial investigation characterized the pharmacokinetic (PK) and subjective effects of a novel sublingual (SL) nicotine tablet designed to deliver nicotine more rapidly to the bloodstream of smokers.MethodsStudy 1 (N= 6) characterized the pharmacokinetics of a 2 mg nicotine SL tablet in comparison to an FDA-approved, marketed 2 mg nicotine lozenge. Study 2 (N= 24) assessed subjective responses of smokers to a single use of a 1 mg and 2 mg SL tablet.ResultsStudy 1 found that the time to maximum blood nicotine concentrations was significantly shorter for the SL tablet (14 min) than for the lozenge (82 min), and the initial rate of nicotine absorption was higher (0.4 ng/mL*min vs. 0.0 ng/mL*min), supporting the hypothesis that the SL tablet delivered nicotine more rapidly. Study 2 found that participants reported immediate relief of nicotine withdrawal symptoms after tablet administration, and craving reduction after the 2 mg tablet approached the degree reported for their usual brands of cigarettes (4.2 vs. 4.6 on a 7-point scale). Other subjective responses showed the tablet to be an appealing alternative to smoking.ConclusionsThe novel SL tablet studied shows promise as a nicotine substitution strategy for tobacco harm reduction and smoking cessation treatment. Additional studies are warranted to further investigate the potential of this new approach.