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）：潜在减少暴露产品（PREP）代表了烟草行业降低烟草使用相关风险的最新策略。最新一代的PREP包括口服、不燃无烟产品。虽然全面的风险状况尚不清楚，但一些短期的有毒物质暴露实验室研究表明，与传统卷烟相比，无烟烟草的危害可能会减少。相比之下，有有限的证据来确定是否PREPs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）研究了PREP，特别是口服无烟烟草对吸烟和戒烟行为的影响（例如，退出尝试）。这一关键问题仍然没有答案，但它是烟草控制领域内有争议的辩论的根源。一些间接证据表明，无烟烟草可以促进戒烟，而不是破坏它。来自欧洲的流行病学数据观察到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），这两项研究都表明无烟烟草对促进戒烟有潜在的好处。如果得到证实，这将具有重要的临床和政策意义，特别是对于大多数仍然不愿意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（N= 1，250）和最长（1年）的口服不可燃烟草RCT（即，骆驼鼻烟）作为一种戒烟诱导的手段，在吸烟者谁，否则没有动机戒烟。将通过既定方法主动招募基于人群的全国范围吸烟者样本，同意参加基于电话的戒烟诱导试验，并随机分配至a）提供骆驼鼻烟或B）不提供。研究人员以前已经证明了这种方法的可行性-既有效地招募和有效地留住大量的无动机吸烟者。尽管将跟踪许多结果，但研究人员的主要目标是检查1）鼻烟使用对吸烟行为的影响（例如，戒烟尝试，戒烟，减少吸烟），2）这种关系的中介机制，和3）骆驼鼻烟的吸收和使用程度（包括患病率，数量和使用模式）。在PREP广泛流行之前，客观评估PREP对戒烟尝试的影响至关重要。考虑到最近的立法规定FDA对烟草的监管权，这一申请特别及时。这项研究的主要意义是它有可能澄清一个新开发的和积极销售的PREP的人口影响，特别是对大多数仍然没有戒烟动机的吸烟者。该研究将提供强有力、明确和客观的证据，以指导这一有争议的烟草控制领域的临床和监管决策。 公共卫生相关性：烟草工业已经开发了许多新型无烟烟草产品，据称与传统香烟相比，这些产品提供了降低的健康风险。吸烟者如何使用这些产品，以及它们如何影响戒烟，目前尚不清楚。使用一项大型，长期，随机临床试验，本研究探讨了在无戒烟动机的吸烟者中使用口服，无烟，减少暴露的烟草产品的影响，特别关注随后的戒烟尝试和相关的吸烟和戒烟行为。