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：非日常吸烟者或间歇性吸烟者（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有严重的吸烟相关的发病率和死亡率，然而DHHS的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吸烟行为中的作用尚未得到很好的确定。我们小组对ITS的深入研究揭示了他们吸烟的矛盾本质：他们一次自愿戒掉几天，没有任何渴望或戒断症状的证据，然而ITS也表现出尼古丁依赖的迹象。我们对全国数据的分析表明，ITS在戒烟方面有困难：尽管他们比常规的日常吸烟者（DS）更努力地戒烟，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，包括药物治疗。相当一部分ITS有“毕业”到每天长期吸烟的风险。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环境中，促使吸烟（例如，社交和社交活动）

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. .