A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.
A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.
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一项两臂，两臂，34周，双盲，平行组，随机对照试验，是烟气和/或焦虑症的吸烟者中尼古丁香烟减少的试验：试验设计和方案。
DOI：
10.1186/s12889-016-3946-4
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发表时间：
2017-01-19
影响因子：
4.5
通讯作者：
Evins AE
中科院分区：
文献类型：
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作者：
Allen SI;Foulds J;Pachas GN;Veldheer S;Cather C;Azzouz N;Hrabovsky S;Hameed A;Yingst J;Hammett E;Modesto J;Krebs NM;Zhu J;Liao J;Muscat JE;Richie J;Evins AE
美国食品和药物管理局可以为卷烟制定标准，其中可能包括降低尼古丁含量。这样的标准应能改善公共卫生，而不会对亚群体造成意外的严重后果。本研究采用一项双中心、双臂、双盲、平行组、随机对照试验（RCT），分4个阶段进行，为期34周，评价了逐步减少香烟中尼古丁含量对伴发情绪和/或焦虑障碍的吸烟者的吸烟行为、毒物暴露和精神症状的影响。每天吸烟5支或以上的成年吸烟者（N = 200）将随机分配至两个研究中心（宾夕法尼亚州立大学和马萨诸塞州综合医院）。参与者必须在前一个月内没有戒烟尝试，也没有计划在未来6个月内戒烟，符合基于结构化小型国际神经精神访谈的当前或终身单极情绪和/或焦虑障碍的标准，并且不得有不稳定的医疗或精神状况。在抽了一周自己的香烟后，参与者接受了两周的光谱研究香烟，其尼古丁含量通常为11.6毫克。在该基线期后，受试者将被随机分配继续吸烟Spectrum研究香烟，其中含有（a）尼古丁含量（11.6 mg）;或（B）尼古丁含量降低：每支香烟的尼古丁含量在18周内分5步从约11.6 mg逐渐降低至0.2 mg。在随机化阶段结束时，将为受试者提供以下选择：（a）在帮助下戒烟，（B）在研究的最后12周继续吸烟，或（c）重新购买自己的香烟。主要结局指标是血可替宁;关键次要结局指标是：呼出的一氧化碳、尿总NNAL-4-（甲基亚硝胺）-1-（3-吡啶基）-1-丁醇和1-羟基芘、氧化应激生物标志物（包括8-异前列腺素）、精神症状指标（例如，抑郁，焦虑），吸烟行为和依赖（例如，香烟消费，戒烟尝试），和健康影响（例如，血压、呼吸道症状）。这项研究的结果将告知FDA关于调节香烟尼古丁含量的潜在影响，并帮助确定患有情绪和/或焦虑症的吸烟者是否可以安全地过渡到尼古丁含量显著降低的香烟。TRN：NCT 01928758，2013年8月21日注册。
The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks. Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms). Results from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes. TRN: NCT01928758, registered August 21, 2013.