Cessation in Non-Daily Smokers: A RCT of NRT with Ecological Momentary Assessment

描述（由申请人提供）：美国的吸烟模式正在发生巨大变化：非每日或间歇性吸烟者（ITS）现在占美国所有成年吸烟者的四分之一或更多，并且正在急剧上升。ITS遭受严重的吸烟相关的发病率和死亡率，但DHHS指南强调，明显缺乏证据来指导这一群体的治疗。此外，尼古丁在ITS吸烟行为中的作用还没有得到很好的确定。我们小组对ITS的深入研究揭示了他们吸烟的矛盾性质：他们自愿戒烟几天，没有渴望或戒断症状的证据，但ITS也表现出尼古丁依赖的迹象。我们对国家数据的分析表明，ITS戒烟有困难：尽管他们比普通的每日吸烟者（DS）更努力戒烟，但ITS试图戒烟的失败率高达79%-几乎与DS一样高-并且还寻求戒烟辅助手段，包括药物。很大一部分的ITS有“毕业”到长期每天吸烟的风险。我们自己的原始数据进一步表明，ITS的吸烟是由刺激控制驱动的-暴露于特定的，通常是特殊的刺激和促使吸烟的情况（例如，社会 场地、压力）。这表明再次暴露于这些刺激可能在ITS的复发中起很大作用，并且在这些情况下，ITS可能受益于急性剂量的尼古丁。口服尼古丁药物，如尼古丁口香糖，我们已经证明，以减少急性线索引起的渴望在日常吸烟者，是理想的适合提供这样的急性“救援”治疗。我们的首要目标是研究按需口服尼古丁替代疗法（NRT）- 2 mg尼古丁口香糖-在ITS中戒烟的效果，并使用生态瞬时评估（EMA）研究其复发过程。对ITS的回顾呼吁对ITS的复发过程进行研究，并对ITS中的停止方法（包括药物）进行评估。然而，迄今为止还没有研究检查ITS中的停止或复发过程，或测试NRT在该人群中的使用。我们提出了一个双盲，随机，安慰剂对照试验的口服NRT戒烟的ITS。600名有兴趣离职的合资格智能交通服务人员将通过 多个通道，入组，并以1：1的比例随机分配至活性NRT组与安慰剂组。参与者将参加6次简短的行为支持会议，并在第2周计划戒烟一天。将对长期禁欲进行评估和生化验证。EMA数据收集跨越两周的随意吸烟和戒烟日期后的另外6周，以捕获ITS中的渴望、戒断和复发数据，并将复发背景与基线吸烟模式相关联。更好地了解ITS吸烟以及如何帮助他们戒烟对公共卫生至关重要：它不仅可以帮助相当一部分迄今被忽视的吸烟者， 战略性地预测未来的科学、治疗和公共卫生需求， ITS的比例继续增长。此外，评估尼古丁药物对ITS戒烟的影响将有助于了解尼古丁在ITS吸烟和戒烟困难中的作用。.

DESCRIPTION (provided by applicant): US smoking patterns are changing dramatically: non-daily, or intermittent smokers (ITS), now comprise a quarter or more of all adult smokers in the US and are rising dramatically. ITS suffer serious smoking- related morbidity and mortality, yet DHHS guidelines underscore the distinct lack of evidence to guide therapy for this group. Moreover, the role of nicotine in ITS' smoking behavior is not well established. Our group's intensive study of ITS revealed the paradoxical nature of their smoking: they voluntarily abstain for days at a time without evidence of craving or withdrawal symptoms, yet ITS also exhibit signs of nicotine dependence. Our analyses of national data demonstrate that ITS have trouble quitting: Although they make more efforts to quit than regular daily smokers (DS), ITS trying to quit have failure rates of up to 79%- almost as high as those of DS-and also seek out quit aids, including medications. A substantial portion of ITS are at risk of "graduating" to daily smoking long term. Our own primary data further show that ITS' smoking is driven by stimulus control - exposure to specific, often idiosyncratic, stimuli and situations that prompt smoking (e.g., social venues, stress). This suggests that re-exposure to such stimuli may play a large role in relapse among ITS, and that ITS may benefit from acute doses of nicotine in those situations. Oral nicotine medication such as nicotine gum, which we have shown to reduce acute cue-provoked craving in daily smokers, is ideally suited to provide such acute 'rescue' treatment. Our overarching aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in ITS, and to study their process of relapse using Ecological Momentary Assessment (EMA). Reviews of ITS have called for research on ITS' relapse process, and for evaluation of cessation methods, including medications, among ITS. Yet no study to date has examined the cessation or relapse process in ITS, or tested the use of NRT in this population. We propose a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 eligible ITS interested in quitting will be recruited through multiple channels, enrolled, and randomized 1:1 to active NRT vs. placebo. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Long term abstinence will be assessed and biochemically validated. EMA data collection spans two weeks of ad lib smoking and 6 additional weeks following the quit date, to capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns. Developing a better understanding of ITS' smoking and of how to help them quit is essential to public health: it will not only assist a substantial fraction of hitherto-ignored smokers, but also strategically anticipate upcoming scientific, treatment, and public health needs that will arise if the proportion of ITS continues to grow. Further, assessing the effect of nicotine medications on ITS' quitting will shed light on the role of nicotine in ITS' smoking and difficulty quitting. .