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

非日常吸烟者的戒烟：NRT 的随机对照试验及生态瞬时评估

• 批准号: 8576006
• 负责人: Hilary A. Tindle
• 金额: $ 66.36万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8576006
• 关键词: Abstinence; Acute; Address; Adult; Behavioral; Belief; Cigarette; Clinical Treatment; Cues; Data; Data Collection; Dependence; Distress; Dose; Double-Blind Method; Enrollment; Evaluation; Exhibits; Exposure to; Failure; Frequencies; Guidelines; Individual; Learning; Light; Methods; Moods; Morbidity - disease rate; Nature; Nicotine; Nicotine Dependence; Oral; Participant; Pattern; Pharmaceutical Preparations; Pharmacological Treatment; Placebos; Play; Population; Process; Public Health; Randomized; Recording of previous events; Recruitment Activity; Regulation; Relapse; Reporting; Research; Research Subjects; Residual state; Risk; Role; Smoke; Smoker; Smoking; Smoking Behavior; Staging; Stimulus; Stress; Testing; Time; Treatment Efficacy; Withdrawal; Withdrawal Symptom; addiction; base; craving; experience; follow-up; improved; interest; mortality; nicotine gum; nicotine replacement; public health relevance; randomized placebo controlled trial; randomized trial; smoking cessation; smoking relapse; social; theories

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. .

描述（由申请人提供）：美国吸烟模式正在发生巨大变化：非每日或间歇性吸烟者（ITS），现在构成了美国的四分之一或更多的成年吸烟者，并且正在急剧上升。它具有严重的吸烟 - 发病率和死亡率，但DHHS指南强调了明显缺乏指导该组治疗的证据。此外，尼古丁在其“吸烟行为”中的作用尚未确定。我们小组对其的深入研究揭示了他们吸烟的矛盾性质：他们一次自愿戒除几天，而没有渴望或戒断症状的证据，但它也表现出尼古丁依赖性的迹象。我们对国家数据的分析表明，它的戒烟很难：尽管他们比普通的日常吸烟者（DS）更大的努力戒烟，但它试图退出的失败率最高为79％，几乎与DS的失败率高 - 还寻找戒烟辅助工具，包括药物。它的很大一部分有可能长期“毕业”到每天吸烟的风险。我们自己的主要数据进一步表明，它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，社交 场地，压力）。这表明重新暴露于这种刺激中可能在其复发中起着很大的作用，并且在这些情况下，它可能会受益于急性剂量的尼古丁。我们已经证明，尼古丁口香糖（例如尼古丁口香糖）（我们已证明可以减少急性提示的渴望在日常吸烟者中的渴望），非常适合提供这种急性的“救援”治疗。我们的总体目的是研究所需的口服尼古丁替代疗法（NRT）-2 mg尼古丁口香糖的作用，以便在其中戒烟，并使用生态瞬时评估（EMA）研究其复发过程。对其复发过程以及评估戒烟方法（包括药物）的评论呼​​吁进行研究。然而，迄今为止，还没有研究检查其停止或复发过程，或者在该人群中测试了NRT的使用。我们提出了口服NRT的双盲，随机，安慰剂对照试验，以戒烟。 600符合条件的兴趣将通过 多个通道，已注册和随机的1：1与Active NRT与安慰剂相比。参与者将在第2周的计划中进行6次会议，并在第2周举行戒烟日。 EMA数据收集涵盖了两周的AD LIB吸烟，并在退出日期后另外6周，以捕获有关其渴望，戒断和复发的数据，并将复发环境与基线吸烟模式相关联。对其“吸烟和如何帮助他们退出对公共卫生至关重要：它不仅有助于大量迄今为止的吸烟者，而且还可以 从战略上期望即将到来的科学，治疗和公共卫生需求，如果 它的比例继续增长。此外，评估尼古丁药物对戒烟的影响将阐明尼古丁在吸烟和戒烟中的作用。 。