Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes

 描述（申请人提供）：尽管电子烟（电子烟）上市还不到十年，但自2008年以来，使用量每年翻一番，预计2014年销售额将达到22亿美元。此外，传统烟草业已进入这一市场，预计未来将有更大的增长。对电子烟的研究仍然是 在初期阶段，对它们的健康后果、成瘾倾向和作为戒烟工具的潜力存在开放性问题。电子烟不受管制，因此不能公开销售作为治疗烟草依赖的药物疗法，但调查研究发现，使用电子烟的主要动机是帮助戒烟或减少吸烟。尽管数百万吸烟者同时使用电子烟（双重使用者），通常是为了戒烟，但他们通常在没有接受任何行为帮助的情况下这样做。尽管使用者的意图，双重使用可能会保持烟草依赖，因为在禁止吸烟时允许尼古丁输送，同时使双重使用者暴露于与长期使用电子烟相关的额外的、迄今未知的健康风险。存在帮助大量双重使用者的机会，即已经通过开始使用电子烟而表现出戒烟的初步行动的吸烟者-戒烟和最终的电子烟戒烟。这个自然发生的，自我选择的，和动机的群体可能是理想的，从最低限度的干预，可以提高他们实现和保持烟草和尼古丁戒断的机会受益。本申请的主要目的是：（1）通过系统的形成过程来调整经验证的自助戒烟干预，以满足当前双重使用者的需求;（2）在2500名双重使用者的随机对照试验（RCT）中测试这种新的干预;以及（3） 计算干预的成本效益。我们之前的研究已经证明，一系列的自助小册子可以促进戒烟和减少复发。我们将为双重用户调整此干预。在随机对照试验中，新的干预措施将与无治疗（仅评估）和现有的非针对性戒烟手册进行比较。随访将持续到入组后24个月，结果将包括戒烟和电子烟。第二个目的是收集关于烟草和电子烟使用模式以及双重使用者停止使用任何产品的过程的纵向数据。这个项目测试双重用途的高风险行为是否可以利用，以促进 戒烟，并最终停止所有尼古丁产品。

 DESCRIPTION (provided by applicant): Although electronic cigarettes (e-cigarettes) have been on the market for less than a decade, use has been doubling each year since 2008, and sales are projected to reach $2.2 billion in 2014. Moreover, the traditional tobacco industry has moved into this market, projecting greater growth in the future. Research on e- cigarettes is still in the nascent stage, with open questions about their health consequences, addiction liability, and potential as a smoking cessation tool. E-cigarettes are not regulated-and therefore cannot be overtly marketed-as pharmacotherapy for treating tobacco dependence, yet survey research has found that the primary motivations for their use are to aid smoking cessation or smoking reduction. Although millions of tobacco smokers are simultaneously using e-cigarettes (dual users), often for the purpose of quitting smoking, they usually do so without receiving any behavioral assistance. Despite users' intentions, dual use may maintain tobacco dependence by allowing nicotine delivery when smoking is prohibited, while simultaneously exposing dual users to additional, as-yet-unknown health risks associated with chronic e-cigarette use. The opportunity exists to assist the large population of dual users-smokers who have already demonstrated initial action toward smoking cessation by commencing use of e-cigarettes-with smoking cessation and eventual e- cigarette cessation. This naturally-occurring, self-selected, and motivated group may be ideally primed to benefit from a minimal intervention that may enhance their chances of achieving and maintaining tobacco and nicotine abstinence. The primary aims of the present application are: (1) to adapt via a systematic, formative process a validated self-help, smoking-cessation intervention to meet the needs of current dual users; (2) to test this new intervention in a randomized controlled trial (RCT) of 2500 dual users; and (3) to calculate the cost- effectiveness of the intervention. Our previous research has demonstrated that a series of self-help booklets can enhance smoking cessation and reduce relapse. We will adapt this intervention for dual users. In the RCT, the new intervention will be compared to both no-treatment (assessment-only) and existing, non-targeted smoking cessation manuals. Follow-up will occur through 24 months post-enrollment, and outcomes will include both cigarette and e-cigarette cessation. A secondary aim is to gather longitudinal data regarding the patterns of tobacco and e-cigarette use and the course of cessation of either product among dual users. This project tests whether the high-risk behavior of dual use can be capitalized upon to facilitate smoking cessation and, ultimately, cessation of all nicotine products.