Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial

Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial
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DOI:
10.1136/tc.2009.031567
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发表时间:
2010-04-01
期刊:
影响因子:
5.2
通讯作者:
Laugesen, M.
Laugesen, M.
中科院分区:
医学2区
文献类型:
--
作者:
Bullen, C.;McRobbie, H.;Laugesen, M.

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目的测量电子尼古丁输送装置的短期效应设计Ruyan V8 ENDD的单盲随机重复测量交叉试验。设置奥克兰大学研究中心,新西兰。参与者40名成人依赖吸烟者的10支或更多的香烟每天。干预参与者被随机使用ENDD含有16毫克尼古丁或0毫克胶囊,在4个研究日的每一天,间隔3天,使用尼古丁吸入器或他们常用的香烟,在使用每种产品之前整夜戒烟。在使用前和使用1小时后,以11点视觉模拟量表上的“曲线下面积”测量。次要结局包括戒断症状、可接受性和不良事件。在9名参与者中,血清尼古丁水平也measured.Results超过60分钟,使用16毫克ENDD的参与者记录0.82单位的吸烟欲望比安慰剂ENDD(p=0.006)。16 mg ENDD和吸入器之间的吸烟欲望没有差异。与吸入器相比,ENDD使用更舒适(p=0.016),对口腔和咽喉的刺激更少(p
Objectives To measure the short-term effects of an electronic nicotine delivery device ("e cigarette", ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects.Design Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD.Setting University research centre in Auckland, New Zealand.Participants 40 adult dependent smokers of 10 or more cigarettes per day.Interventions Participants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product.Main outcome measures The primary outcome was change in desire to smoke, measured as "area under the curve" on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured.Results Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p