A randomized controlled trial of smoking cessation treatment for young adult dual users of combustible and electronic cigarettes

对同时使用可燃烟和电子烟的年轻成人进行戒烟治疗的随机对照试验

• 批准号: 10292910
• 负责人: Elias Mushabac Klemperer
• 金额: $ 10.79万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10292910
• 关键词: Abstinence; Acute; Adult; Adverse event; Behavior; Cigarette Smoker; Electronic cigarette; Health; Life; Nicotine; Nicotine Dependence; Outcome; Participant; Population; Prevalence; Publishing; Randomized; Randomized Controlled Trials; Research; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Testing; Text Messaging; Tobacco; United States; Vermont; base; cigarette smoking; combustible cigarette; effectiveness testing; electronic cigarette use; electronic cigarette user; follow-up; mortality; nicotine replacement; primary outcome; smoking cessation; young adult

Over 480,000 people die per year from combustible cigarette (CC) smoking related illness in the United States. Young adults are particularly vulnerable to nicotine dependence and harm from tobacco. The prevalence of electronic cigarette (EC) use has increased exponentially over the past decade and is highest among young adults. ECs could substantially reduce harm for young adult smokers who completely switch from CCs to ECs and remain abstinent from CCs. However, most who use ECs continue to smoke CCs (i.e., dual users), which could perpetuate nicotine dependence and harm from CC smoking. There are no empirically based treatments for dual users and it is unclear whether quitting CCs only or quitting both CCs and ECs simultaneously is more effective to achieve long-term abstinence from CCs. Nicotine replacement therapy (NRT) is an effective first-line smoking cessation treatment for adult CC smokers but has never been tested among young adults or among dual users. Given the strong evidence that smoking cessation early in life can completely avoid tobacco-related mortality, there is a need to test effective smoking cessation treatment for young adult dual users. The overarching aim of the proposed 2x2 factorial RCT is to test NRT with text message support for two smoking cessation approaches among young adult dual users of CCs and ECs. Specifically, we aim to 1) test the effectiveness of NRT for CC cessation among young adult dual users and 2) test whether quitting CCs only versus quitting CCs and ECs simultaneously is more effective to achieve CC abstinence. Participants (n=390) will be randomized to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. Our primary outcome will be CO-verified 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). Findings from our primary aims will directly inform smoking cessation treatment for young adult dual users, a population that is particularly vulnerable to the harmful effects of nicotine addiction. This is important given the current lack of published research on smoking cessation treatment for dual users or NRT for young adults. As secondary aims, we will explore the interaction between NRT use versus no use and quitting CCs only versus CCs and ECs simultaneously as well as change in nicotine dependence, demand, and other smoking related outcomes among participants who fail to quit. Broadly, findings will have applied implications for treating young adult dual users and scientific implications regarding the effects of quitting one (CCs) versus two (CCs and ECs) nicotine products simultaneously.

在美国，每年有超过480，000人死于与可燃香烟（CC）吸烟相关的疾病 美国的年轻人特别容易受到尼古丁依赖和烟草危害的影响。 电子烟（EC）的使用在过去十年中呈指数级增长， 在年轻人中最高。ECs可以大大减少年轻成年吸烟者的伤害， 完全从CC转换到EC，并保持对CC的禁欲。然而，大多数使用EC的人 继续抽吸CC（即，双重使用者），这可能会使尼古丁依赖和危害永久化， CC吸烟目前还没有针对双重使用者的基于经验的治疗方法， 只有CC或同时退出CC和EC更有效地实现长期 戒CC。尼古丁替代疗法（NRT）是一种有效的一线戒烟方法 但从未在年轻人或双重使用者中进行过测试。 鉴于有强有力的证据表明，在生命早期戒烟可以完全避免与烟草有关的 死亡率，有必要测试有效的戒烟治疗的年轻成人双重用户。 拟议的2x2析因RCT的总体目标是测试NRT与文本消息支持， 两种戒烟方法在年轻成人的CC和EC双重用户。我们特别 目的是1）测试NRT在年轻成人双重使用者中停止CC的有效性，2）测试 是否仅退出CC或同时退出CC和EC更有效地实现CC 禁欲受试者（n=390）将随机接受A）NRT加短信以退出CC 仅限，B）NRT加短信同时退出CC和EC，C）仅短信退出 仅CC，或D）单独发送短信以同时退出CC和EC。我们的主要成果将是 治疗结束时经CO验证的7天时点戒烟率（即，后3个月 随机化）。 从我们的主要目标的结果将直接告知戒烟治疗的年轻成人双重 吸烟者是一个特别容易受到尼古丁成瘾有害影响的人群。这是 鉴于目前缺乏关于双重使用者戒烟治疗的已发表研究，这一点很重要， NRT对于年轻人来说。作为次要目的，我们将探讨使用NRT与不使用NRT之间的相互作用。 仅使用和戒烟CC与同时使用CC和EC以及尼古丁的变化 依赖，需求和其他吸烟相关的结果在参与者谁未能戒烟。 从广义上讲，研究结果将对治疗年轻成人双重使用者和科学 关于戒烟一种（CC）与两种（CC和EC）尼古丁产品效果的影响 同步