Evaluation of a Novel Nicotine Inhaler Device: Part 2-Effect on Craving and Smoking Urges
Evaluation of a Novel Nicotine Inhaler Device: Part 2-Effect on Craving and Smoking Urges
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DOI：
10.1093/ntr/ntu122
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发表时间：
2015-01-01
影响因子：
4.7
通讯作者：
Redfern, Andrew
中科院分区：
文献类型：
--
作者：
Moyses, Chris;Hearn, Alex;Redfern, Andrew
导语：许多吸烟者发现目前可用的尼古丁替代疗法并不令人满意。通过一种新型吸入器释放尼古丁的药代动力学，以及它对渴望饱腹感和吸烟冲动的影响，与Nicorette(R)吸入器(10 Mg)进行了比较。方法：报道了一项4部分I期研究中B部分(N=24)和D部分(N=24)的结果。参与者(18-55岁，清醒后1小时内每天抽10支烟，一氧化碳过期；筛查时为10ppm)连续几天接受单剂尼古丁(0.45和0.67毫克[B部分]和0.45毫克[D部分]；10毫克通过Nicorette(R)[B部分和D部分])。结果：在B部分，0.45和0.67 mg的新型缓释片的C-max、AUC(LAST)和AUC(ALL)均显著低于Nicorette(R)(P均<0.05)。
Introduction: Many smokers find currently available nicotine replacement therapies unsatisfactory. The pharmacokinetics of nicotine delivered via a novel inhaler device, and its effect on craving satiation and smoking urges, were compared with the Nicorette (R) Inhalator (10 mg).Methods: Results are reported for Parts B (N = 24) and D (N = 24) of a 4-part Phase I study. Participants (18-55 years, >= 10 cigarettes/day within 1 hr of waking, expired carbon monoxide > 10 ppm on screening) received single doses of nicotine on consecutive days (0.45 and 0.67 mg [Part B] and 0.45 mg [Part D] via the novel device; 10 mg via Nicorette (R) [Parts B and D]). Venous pharmacokinetics, craving, and tolerability were assessed.Results: In Part B, the novel device 0.45 and 0.67 mg produced significantly lower C-max, AUC(last), and AUC(all) than Nicorette (R) (all p