Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

描述（由申请人提供）：经常使用无烟烟草（ST）是一个严重的公共卫生问题。大多数烟草治疗方案不提供具体的性传播疗法干预措施，性传播疗法使用者很少或根本无法获得烟草治疗方案。因此，有必要开发具有成本效益的可广泛传播的性传播技术干预措施。我们早期的研究表明，使用邮寄材料和电话支持的行为自助干预可以长期停止性行为。虽然大多数尼古丁替代干预措施对ST使用者来说都令人惊讶地无效，但尼古丁含片却显示出了令人鼓舞的效果。我们最近证明，在随访中使用尼古丁含片增加了所有烟草和ST烟草戒断率，一项试点研究表明，在辅助自助干预的背景下，由尼古丁含片组成的ST干预是可行的。这项研究的下一步是测试尼古丁含片和辅助自助相结合的最小接触干预的有效性和成本效益，这种干预可以广泛推广。目的：我们提出一项三组随机对照试验，严格测试三种戒烟方案的有效性：(a)结合使用尼古丁含片和辅助自助电话咨询（LASH）的情况；(b)只接受辅助自助（ASH：包括电话支持）的情况；(c)接受含片和自助材料（LSH）的最小接触条件。方法：一个多方面的，数据驱动的营销和推广计划将被用来招募1011 ST用户。潜在的参与者将拨打免费招募热线进行初步筛选。完成邮寄登记包（知情同意和基线评估）的个人将被随机分配到三种情况中的一种，并通过邮件、咨询师的三个电话支持电话和自助材料获得含片的组合。主要结局指标将是自我报告的3个月和6个月随访期间所有烟草使用的长期戒断。我们将在6个月的评估中生化验证禁欲。措施：通过邮寄调查和电话对无应答者进行戒烟结果评估，在入组后3个月和6个月。二次分析将检查基线参与者的特征、项目利用情况以及戒烟的调节因子和中介因子。肝酶活性对尼古丁代谢的探索性测试将作为尼古丁含片功效的潜在调节剂进行测试。我们还将评估在辅助自助干预中添加尼古丁含片（或在锭剂干预中添加辅助自助干预）的每次戒烟的增量成本。好处：这个项目将是第一个关于性烟瘾戒烟的随机对照试验，它将测试使用尼古丁含片和以电话咨询为特征的行为干预的增量效果，以及行为干预是否会增加含片的价值。

DESCRIPTION (provided by applicant): The regular use of smokeless tobacco (ST) represents a serious public health problem. Most tobacco treatment programs do not offer specific ST interventions and ST users have little or no access to tobacco treatment programs. Therefore, a need exists to develop cost effective ST interventions that can be disseminated broadly. Our earlier research demonstrated that behavioral self-help interventions using mailed materials plus telephone support produced long-term ST cessation. While most nicotine replacement interventions have been surprisingly ineffective with ST users, the nicotine lozenge has shown promising results. We recently demonstrated that using nicotine lozenges increased all tobacco and ST tobacco abstinence rates at follow-up and a pilot study demonstrated the feasibility of an ST intervention consisting of nicotine lozenges delivered in the context of an assisted self-help intervention. The next step in this line of research is to test the effectiveness and cost-effectiveness of a minimal contact intervention combining nicotine lozenge and assisted self-help that could be disseminated broadly. Objectives: We propose a three-arm RCT that rigorously tests the effectiveness of three ST cessation programs: (a) a condition that combines the use of nicotine Lozenges and Assisted Self-Help phone counseling (LASH) (b) a condition that receives only the Assisted Self-Help (ASH: including phone support), and (c) a minimal contact condition that receives Lozenges and Self-Help materials (LSH). Methods: A multifaceted, data-driven marketing and promotion plan will be used to recruit 1011 ST users. Prospective participants will call a toll-free recruitment line for preliminary screening. Individuals who complete a mailed enrollment packet (informed consent and baseline assessment) will be randomized to one of the three conditions and receive a combination of lozenges via the mail, three telephone support calls from a counselor and self-help materials. The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up. We will biochemically verify abstinence at the 6 month assessment. Measures: Tobacco abstinence outcomes will be evaluated at 3 months and 6 months post-enrollment via mailed surveys and phone calls to non-responders. Secondary analyses will examine baseline participant characteristics, program utilization, and moderators and mediators of tobacco abstinence. An exploratory test of liver enzyme activity on the metabolism of nicotine will be tested as a potential moderator for the efficacy of the nicotine lozenge. We will also assess the incremental cost-per-quit of adding nicotine lozenges to an assisted self-help intervention (or of adding an assisted self-help intervention to a lozenge intervention). Benefits: This project will be the first RCT for ST cessation that tests the incremental effectiveness of using nicotine lozenges along with a behavioral intervention featuring phone counseling and also whether the behavioral intervention adds value to the lozenges. PUBLIC HEALTH RELEVANCE: There is a need for a smokeless tobacco cessation program that is cost effective and has the potential to reach this group of underserved tobacco users. Using a three-arm design, we propose to evaluate the effectiveness and cost-effectiveness of combining a validated behavioral intervention with a promising Nicotine Replacement Therapy-the Lozenge-compared to either intervention alone.