A Novel Trial of Smokeless Tobacco for Cessation Induction in Unmotivated Smokers

描述（由申请人提供）：潜在减少暴露产品（prep）代表了烟草业减少与烟草使用相关风险的最新策略。最新一代的预燃产品包括口服、不燃无烟产品。尽管全面的风险状况尚不清楚，但一些短期的有毒物质接触实验室研究表明，与传统香烟相比，无烟烟草的危害可能更小。相比之下，确定预防措施最终是否破坏或促进公共卫生的证据有限。更具体地说，很少有随机临床试验（rct）研究预吸烟产品，特别是口服无烟烟草对吸烟和戒烟行为（如戒烟尝试）的影响。这一关键问题仍未得到解答，但却是烟草控制领域内争论不休的根源。一些间接证据表明，无烟烟草可以促进戒烟，而不是破坏戒烟。来自欧洲的流行病学数据显示，无烟烟草的使用与戒烟增加有关。仅有的两项随机研究报告了吸烟行为的预期变化（其中一项来自本实验室），都表明无烟烟草对戒烟有潜在的好处。如果得到证实，这将具有重要的临床和政策意义，特别是对大多数仍然不愿或不能戒烟的吸烟者。为了解决这一证据上的差距，研究人员提出了最大（N=1,250）和最长（1年）的口服不燃烟草（即骆驼鼻烟）的随机对照试验，作为诱导那些没有戒烟动机的吸烟者戒烟的手段。将通过既定方法主动招募以人群为基础的全国吸烟者样本，同意参加以电话为基础的戒烟诱导试验，并随机分为A)提供骆驼鼻烟或b)不提供。研究人员先前已经证明了这种方法的可行性——既可以有效地招募，也可以有效地留住大量的无动机吸烟者。虽然将跟踪许多结果，但调查人员的主要目的是检查1)使用鼻烟对吸烟行为的影响（例如，戒烟尝试，戒烟，减少吸烟），2)这种关系的中介机制，以及3)摄取和使用骆驼鼻烟的程度（包括流行程度，数量和使用模式）。在prep广泛普及之前，客观评估其对戒烟尝试的影响是至关重要的。鉴于最近的立法赋予FDA对烟草的监管权力，这一申请尤其及时。这项研究的主要意义在于它有可能阐明新开发和积极推广的PREP对人口的影响，特别是对大多数仍然没有戒烟动机的吸烟者。这项研究将提供有力、清晰和客观的证据，指导这一有争议的烟草控制领域的临床和监管决策。

DESCRIPTION (provided by applicant): Potentially reduced exposure products (PREPs) represent the latest strategy by the tobacco industry to reduce risks associated with tobacco use. The most recent generation of PREPs includes oral, non-combustible smokeless products. Although a comprehensive risk profile remains unclear, a number of short-term lab studies of toxicant exposure suggest smokeless tobacco could offer reduced harm as compared to conventional cigarettes. In contrast, there is limited evidence to determine if PREPs ultimately undermine or promote public health. More specifically, few randomized clinical trials (RCTs) have examined the impact of PREPs, particularly oral smokeless tobacco, on smoking and quit behavior (e.g., quit attempts). This critical issue remains unanswered, and yet is the source of contentious debate within the field of tobacco control. Several lines of indirect evidence suggest that smokeless tobacco could promote smoking cessation, not undermine it. Epidemiological data from Europe have observed smokeless tobacco use to be associated with increased quitting. The only two randomized studies to report on prospective changes in smoking behavior (one from this lab) both suggest a potential benefit of smokeless tobacco to enhance quitting of cigarettes. If substantiated, this would have important clinical and policy implications, particularly for the majority of smokers who remain unwilling or unable to quit. To address this gap in the evidence, the investigators propose the largest (N=1,250) and longest (one year) RCT of oral, non-combustible tobacco (i.e., Camel Snus) as a means of cessation induction among smokers who are otherwise unmotivated to quit. A population-based, nationwide sample of smokers will be proactively recruited through established methods, consented to enroll in a telephone-based cessation induction trial, and randomized to either a) provision of Camel Snus, or b) not. The investigators have demonstrated previously the feasibility of this approach -- both to efficiently recruit and effectively retain large numbers of unmotivated smokers. Though a number of outcomes will be tracked, the investigators' primary aims are to examine 1) the impact of Snus use on smoking behavior (e.g., quit attempts, cessation, smoking reduction), 2) mediational mechanisms of this relationship, and 3) extent of uptake and usage of Camel Snus (including prevalence, amount, and patterns of use). It is critical to objectively assess the impact of PREPs on quit attempts before they reach wide popularity. This application is particularly well-timed given recent legislation that provides the FDA with regulatory authority over tobacco. The major significance of this study is its potential to clarify the population impact of a newly developed and aggressively marketed PREP, particularly for the majority of smokers who remain unmotivated to quit. The study will provide strong, clear, and objective evidence to guide clinical and regulatory decision-making for this controversial area of tobacco control.