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ST干预措施，ST使用者很少或根本无法获得烟草治疗方案。因此，需要开发可广泛传播的具有成本效益的ST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会产生长期的ST停止。虽然大多数尼古丁替代干预措施对ST使用者出人意料地无效，但尼古丁含片显示出了令人振奋的结果。我们最近证明，使用尼古丁含片可以增加所有烟草和ST烟草的戒断率，一项试点研究证明了在辅助自助干预的背景下，由尼古丁含片组成的ST干预的可行性。这一系列研究的下一步是测试结合尼古丁含片和辅助自助的最低限度接触干预的有效性和成本效益，这种干预可以广泛传播。目的：我们提出了一种三臂随机对照试验，严格测试三种ST戒断计划的有效性：(A)结合使用尼古丁含片和辅助自助电话咨询(LASH)的条件；(B)仅接受辅助自助(ASH：包括电话支持)的条件；以及(C)接受含片和自助材料(LSH)的最小接触条件。方法：采用多方面的、以数据为导向的营销和推广计划，招募1011名ST用户。潜在参与者将拨打免费招聘热线进行初步筛选。完成邮寄注册信息包(知情同意和基线评估)的个人将被随机分配到三种情况之一，并通过邮件收到含片、顾问打来的三个电话支持电话和自助材料。主要的结果衡量标准将是在3个月和6个月的随访中自我报告长期戒烟情况。我们将在6个月的评估中对禁欲进行生化验证。措施：将在登记后3个月和6个月通过邮寄调查和给无反应者打电话评估戒烟结果。二次分析将检查基线参与者的特征、计划利用情况以及烟草戒除的主持人和中介者。一项关于尼古丁新陈代谢的肝酶活性的探索性测试将被测试为尼古丁含片疗效的潜在缓和剂。我们还将评估在辅助性自助干预中添加尼古丁含片(或在含片干预中添加辅助性自助干预)的戒烟增量成本。好处：这个项目将是第一个针对ST戒烟的随机对照试验，测试使用尼古丁含片的增量有效性，以及以电话咨询为特色的行为干预，以及行为干预是否增加了含片的价值。 与公共健康相关：需要一个成本效益高的无烟戒烟计划，并有可能接触到这一未得到充分服务的烟草使用者群体。使用三臂设计，我们建议评估与一种有前途的尼古丁替代疗法-含片-相结合的有效性和成本效益，与单独干预相比。

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.