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: 8913105
• 负责人: Brian A. Primack
• 金额: $ 61.86万
• 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 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8913105
• 关键词: Abstinence; Acute; Address; Adult; Behavioral; Belief; Cellular Phone; Cigarette; Clinical Treatment; Cues; Data; Data Collection; Dependence; Distress; Dose; Double-Blind Method; Ecological momentary assessment; 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; control theory; 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) 目前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 遭受严重的与吸烟相关的发病率和死亡率，但 DHHS 指南强调明显缺乏指导该群体治疗的证据。此外，尼古丁在 ITS 吸烟行为中的作用尚未明确。我们小组对 ITS 的深入研究揭示了他们吸烟的矛盾本质：他们一次自愿戒烟数天，没有任何渴望或戒断症状的证据，但 ITS 也表现出尼古丁依赖的迹象。我们对全国数据的分析表明，ITS 在戒烟方面遇到了困难：尽管他们比经常吸烟的人 (DS) 更努力戒烟，但 ITS 尝试戒烟的失败率高达 79%，几乎与 DS 一样高，而且寻找戒烟辅助药物，包括药物。很大一部分 ITS 面临“升级”为长期每天吸烟的风险。我们自己的主要数据进一步表明，ITS 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，社交场合） 场地、压力）。这表明，重新暴露于此类刺激可能在 ITS 复发中发挥重要作用，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（例如尼古丁口香糖）非常适合提供这种急性“救援”治疗，我们已经证明尼古丁口香糖可以减少日常吸烟者因提示引起的急性烟瘾。我们的首要目标是研究按需口服尼古丁替代疗法 (NRT)（2 毫克尼古丁口香糖）对 ITS 戒烟的效果，并使用生态瞬时评估 (EMA) 研究其复发过程。对 ITS 的审查要求对 ITS 的复发过程进行研究，并评估 ITS 的戒断方法，包括药物治疗。然而，迄今为止还没有研究检查 ITS 的戒断或复发过程，或测试 NRT 在这一人群中的使用。我们提出了一项口服 NRT 戒烟的双盲、随机、安慰剂对照试验。将通过以下方式招募 600 名有兴趣戒烟的合格 ITS 多渠道、入组并按 1:1 随机分配活性 NRT 与安慰剂。参与者将参加 6 场课程，并提供简短的行为支持，并计划在第 2 周戒烟。长期戒烟将得到评估和生化验证。 EMA 数据收集涵盖随意吸烟的两周和戒烟日期后的另外 6 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联系起来。更好地了解 ITS 吸烟以及如何帮助他们戒烟对于公共卫生至关重要：它不仅可以帮助大部分迄今为止被忽视的吸烟者，而且还可以帮助他们戒烟。 战略性地预测即将出现的科学、治疗和公共卫生需求，如果 ITS的比重持续增长。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。 。