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戏剧性的变化：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，而且还在急剧上升。它遭受着与吸烟相关的严重发病率和死亡率，但DHHS指南强调了明显缺乏证据来指导这一群体的治疗。此外，尼古丁在吸烟行为中的作用还没有得到很好的证实。我们小组对其进行的深入研究揭示了他们吸烟的矛盾性质：他们一次自愿戒烟几天，没有渴望或戒断症状的证据，但也表现出尼古丁依赖的迹象。我们对全国数据的分析表明，它在戒烟方面遇到了困难：尽管他们比正常的日常吸烟者(DS)更努力戒烟，但它试图戒烟的失败率高达79%-几乎与DS的失败率一样高-而且还寻求戒烟辅助手段，包括药物。其中很大一部分人面临着长期“毕业”为日常吸烟的风险。我们自己的初步数据进一步表明，吸烟是由刺激控制驱动的--暴露在特定的、通常是特殊的刺激和促使吸烟的情况下(例如，社交 场馆、压力)。这表明，再次暴露在这种刺激下可能在ITS的复发中起到很大作用，在这种情况下，ITS可能从急性剂量的尼古丁中受益。口服尼古丁药物，如尼古丁口香糖，我们已经证明，它可以减少日常吸烟者由急性暗示引发的渴望，非常适合提供这种急救治疗。我们的总体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中的戒烟效果，并使用生态瞬时评估(EMA)研究他们的复发过程。对其的审查要求对其复发过程进行研究，并对戒烟方法进行评估，其中包括药物治疗。然而，到目前为止，还没有研究检查ITS中的停止或复发过程，也没有测试NRT在这一人群中的使用。我们提出了一项口服NRT用于ITS戒烟的双盲、随机、安慰剂对照试验。将通过以下途径招募600名有兴趣戒烟的合格ITS 多个渠道，登记，并随机1：1到有效的NRT和安慰剂。参与者将参加6次简短的行为支持，计划在第二周戒烟。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临时吸烟和戒烟日期后的另外六周，以捕获ITS中的渴望、戒断和复发的数据，并将复发背景与基线吸烟模式相关联。更好地了解吸烟和如何帮助他们戒烟对公共健康至关重要：这不仅有助于到目前为止被忽视的很大一部分吸烟者，而且还 战略性地预测即将到来的科学、治疗和公共卫生需求，这些需求将在 ITS的比例继续增长。此外，评估尼古丁药物对戒烟的影响将有助于揭示尼古丁在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. .