A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation
A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation
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DOI：
10.1080/14622200802123294
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发表时间：
2008-01-01
影响因子：
4.7
通讯作者：
Albino, Anthony P.
中科院分区：
文献类型：
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作者：
Becker, Karen M.;Rose, Jed E.;Albino, Anthony P.
进行了一项随机双盲、活性对照、平行组、多中心II期临床试验，以评价尼古丁减少型香烟作为一种新型戒烟治疗的疗效（根据研究器械豁免69，185）。减少尼古丁香烟的概念旨在逐步使吸烟者戒除吸烟习惯，这是基于研究表明，成功戒烟不仅取决于尼古丁的戒断，而且还取决于戒除吸烟的习惯性感觉和行为强化。治疗包括Quest品牌香烟（Quest 1、2和3），单独使用或与尼古丁替代疗法（NRT）联合使用时，分别提供0.59 +/- 0.06、0.3 +/- 0.05和小于0.05 mg尼古丁。主要终点是4周的连续戒烟（第7-10周），并在3个月和6个月时进行额外随访。将有戒烟动机的成年男性和女性吸烟者（N=346）随机分配至三个治疗组之一：Quest + NRT（戒烟日期前2周接受NRT预处理，戒烟日期后接受NRT）、Quest+安慰剂贴剂或活性对照+NRT（传统香烟，戒烟日期后接受NRT）。结果显示，Quest + NRT在实现4周持续戒烟方面比活性对照+NRT更有效（32.8% vs. 21.9%）。Quest+安慰剂贴剂的戒烟率与活性对照+NRT相似（16.4% vs. 21.9%）。无严重不良事件可归因于试验用药物。Quest plus NRT有望成为一种新的戒烟治疗方法。
A randomized double-blind, active controlled, parallel group, multi-center phase II clinical trial was conducted to evaluate the efficacy of reduced-nicotine cigarettes as a novel smoking cessation treatment (under Investigational Device Exemption 69,185). The concept for a reduced-nicotine cigarette designed to progressively wean smokers from the smoking habit is based on research demonstrating that successful smoking cessation is not only dependent on withdrawal of nicotine, but also on weaning from the habitual sensory and behavioral reinforcement of smoking. Treatment consisted of Quest brand of cigarettes (Quest 1, 2, and 3), which respectively deliver 0.59 +/- 0.06, 0.3 +/- 0.05, and less than 0.05mg nicotine, either alone or in combination with nicotine replacement therapy (NRT). The primary endpoint was 4 weeks of continuous abstinence (Weeks 7-10), with additional follow-up at 3 and 6 months. Adult men and women smokers (N=346), motivated to quit, were randomized to one of three treatment groups: Quest plus NRT (NRT pretreatment 2 weeks before, and NRT after the quit date), Quest plus placebo patch, or active control plus NRT (conventional cigarette, followed by NRT after quit date). Results showed that Quest plus NRT was more effective than active control plus NRT in achieving 4 weeks of continuous abstinence (32.8% vs. 21.9%). Quest plus placebo patch yielded an abstinence rate similar to that of the active control plus NRT (16.4% vs. 21.9%). No serious adverse events were attributable to the investigational product. Quest plus NRT offers promise as a new smoking cessation treatment.