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

基本信息

批准号：
8634739
负责人：
Matthew J Carpenter
金额：
$ 42.89万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
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/8634739
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 health relevance public policy on tobacco randomized trial response smokeless tobacco cessation smoking cessation smoking restriction snus tobacco control tobacco exposure uptake

项目摘要

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.

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与烟草使用相关的风险的最新策略。最新一代的 PREP 包括口服、不可燃的无烟产品。尽管全面的风险状况仍不清楚，但一些有毒物暴露的短期实验室研究表明，与传统香烟相比，无烟烟草可以减少危害。相比之下，确定 PREP 最终是否会损害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) 检验了 PREP（尤其是口服无烟烟草）对吸烟和戒烟行为（例如，戒烟尝试）的影响。这个关键问题仍未得到解答，但却是烟草控制领域内有争议的争论的根源。一些间接证据表明，无烟烟草可以促进戒烟，而不是破坏戒烟。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。仅有的两项报告吸烟行为预期变化的随机研究（其中一项来自本实验室）均表明无烟烟草对促进戒烟具有潜在益处。如果得到证实，这将产生重要的临床和政策影响，特别是对于大多数仍然不愿意或无法戒烟的吸烟者而言。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（一年）的口服非燃烧烟草（即骆驼鼻烟）随机对照试验，作为无动机吸烟者的戒烟诱导手段戒烟。将通过既定方法主动招募基于人口的全国吸烟者样本，同意参加基于电话的戒烟诱导试验，并随机分为 a）提供骆驼鼻烟或 b）不提供。研究人员此前已经证明了这种方法的可行性——既能有效招募又能有效留住大量无动力的吸烟者。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，以及 3)骆驼鼻烟的吸收和使用程度（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 PREP 对戒烟尝试的影响至关重要。鉴于最近的立法赋予 FDA 对烟草的监管权，这一申请尤其恰逢其时。这项研究的主要意义在于它有可能阐明新开发和积极营销的 PREP 对人群的影响，特别是对于大多数仍然没有戒烟动力的吸烟者。该研究将为这一有争议的烟草控制领域的临床和监管决策提供有力、明确和客观的证据。