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

无烟烟草对无动机吸烟者诱导戒烟的新试验

• 批准号: 8023918
• 负责人: Matthew J Carpenter
• 金额: $ 41.02万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8023918
• 关键词: Abstinence; Address; Area; Behavior; Behavioral; Camels; Cigarette; Clinical; Consent; Data; Decision Making; Denmark; Enrollment; Epidemiology; Europe; Foundations; Generations; Health; Incidence; Individual; Mails; Marketing; Measures; Mediating; Methods; Motivation; Oral; Outcome; Outcome Study; Pattern; Pilot Projects; Population; Prevalence; Public Health; Publishing; Randomized; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Research Personnel; Rest; Risk; Role; Sampling; Science; Self Efficacy; Smokeless; Smokeless Tobacco; Smoker; Smoking; Smoking Behavior; Smoking History; Source; Statutes and Laws; Surveys; Telephone; Testing; Time; Tobacco; Tobacco Industry; Tobacco use; Toxicant exposure; authority; base; behavior test; behavioral health; experience; follow-up; innovation; interest; novel; policy implication; population based; prospective; public policy on tobacco; randomized trial; response; smokeless tobacco cessation; smoking cessation; smoking restriction; snus; tobacco control; tobacco exposure; uptake

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. PUBLIC HEALTH RELEVANCE: The tobacco industry has developed a number of novel smokeless tobacco products that are purported to offer reduced health risks as compared to conventional cigarettes. How smokers use these products, and how they might impact quitting, is unclear. Using a large, long-term, randomized clinical trial, this study examines the impact of using an oral, smokeless, reduced exposure tobacco product among smokers unmotivated to quit, with a specific focus on subsequent quit attempts and related smoking and cessation behavior.

描述（由申请人提供）：可能减少的接触产品（PREP）代表烟草业的最新策略，以减少与烟草使用相关的风险。最近一代的预备包括口服，不可燃烧的无烟产品。尽管尚不清楚全面的风险特征，但许多有关毒性暴露的短期实验室研究表明，与常规香烟相比，无烟烟草可能会减少危害。相比之下，有限的证据可以确定PREP是否最终破坏或促进公共卫生。更具体地说，很少有随机临床试验（RCT）检查了预备的影响，尤其是口服无烟烟草对吸烟和戒烟行为的影响（例如，戒烟尝试）。这个关键问题仍未得到解决，但仍是烟草控制领域中争议性辩论的根源。几条间接证据表明，无烟烟草可以促进戒烟，而不是破坏它。来自欧洲的流行病学数据观察到无烟烟草与戒烟的增加有关。只有两项关于吸烟行为前瞻性变化的随机研究（一个实验室）都表明，无烟烟草的潜在益处可以增强卷烟的戒烟。如果得到证实，这将具有重要的临床和政策影响，特别是对于大多数不愿或无法戒烟的吸烟者。为了解决证据中的这一差距，研究人员提出了最大的（n = 1,250）和最长的（一年）RCT口服，不可耐燃烧的烟草（即骆驼鼻子），作为戒烟的一种戒烟的手段，这些吸烟者本来是无所不能地退出的。将通过既定的方法主动招募基于人群的全国吸烟者样本，同意参加基于电话的戒烟试验，并随机分配给a）提供骆驼鼻子，或b）不提供。研究人员以前证明了这种方法的可行性 - 既可以有效地招募并有效地保留大量未充满动力的吸烟者。尽管将跟踪许多结果，但研究人员的主要目的是检查1）使用鼻子对吸烟行为的影响（例如，戒烟尝试，停止，减少吸烟），2）这种关系的中介机制，3）3）骆驼鼻涕的吸收和用法的程度（包括骆驼鼻子的吸收和用法）（包括预期，量，量和使用模式）。在广泛流行之前，客观地评估预备的影响对戒烟尝试的影响至关重要。鉴于最近立法为FDA提供了对烟草的监管授权，因此该申请尤为适时。这项研究的主要意义在于它的潜力是阐明新开发和积极销售的预备的人口影响，特别是对于大多数戒烟者戒烟的吸烟者而言。该研究将提供有力，清晰和​​客观的证据，以指导烟草控制的这一有争议的领域的临床和监管决策。 公共卫生相关性：与传统香烟相比，烟草业开发了许多新型的无烟烟草产品，这些产品据称可以降低健康风险。吸烟者如何使用这些产品以及如何影响戒烟，尚不清楚。本研究使用大型，长期的随机临床试验，研究了在没有动力戒烟的吸烟者中使用口服，无烟，降低的烟草产物的影响，并特别关注随后的戒烟尝试以及相关的吸烟和戒烟行为。