Enhancing the Effectiveness of Varenicline Based Smoking Cessation Treatment

项目摘要/摘要 吸烟仍然是心血管和肺病的主要可预防原因 疾病。虽然循证治疗提高了吸烟者成功戒烟的机会， 即使有了这样的治疗，大多数吸烟者仍然不能在给定的戒烟时间内长期戒烟 尝试。显然，需要更有效的治疗方法。拟议的研究将 评估两种旨在提高治疗效果的治疗方法 FDA批准的戒烟药物varenicline：1)延长 和2)将尼古丁迷你含片加入到varenicline中形成联合 治疗。虽然现有数据表明，这两项修改都可能大大增强 Varenicline的有效性，两者都没有得到充分的测试。拟议的研究将使用一种 2x2析因设计，将1000名吸烟者随机分为两个因素的两个水平之一： 疗程(12-24周服药)和佐剂(varenicline安慰剂含片vs. Varenicline尼古丁迷你含片)。因此，吸烟者将得到标准的varenicline 治疗(12周的varenicline治疗)或3种创新的强化治疗中的1种：12 数周的varenicline迷你含片，24周的单独varenicline延长治疗，或 使用varenicline迷你含片延长治疗24周。分析将揭示是否 持续时间和佐剂修改对吸烟产生附加或交互影响 戒烟后52周的禁欲是主要结果。此外，计划中的比较将 确定是否有任何增强的条件优于标准的varenicline疗法。这个 假设是24周的持续时间和迷你含片佐剂将产生显著的， 相加主效使其组合(24周伐尼克林迷你含片) 戒烟后52周的戒断率高于标准的12周伐伦克林 治疗。其他结果包括长期戒烟、治疗成本效益、 戒断抑制和不良事件。总而言之，这项研究旨在产生一种 尤其是有效的戒烟治疗，应提高药物性戒烟率 在医疗保健中对吸烟者进行干预，降低患者群体中的吸烟率，以及 减少心血管和肺部疾病的发生率。

PROJECT SUMMARY/ABSTRACT Cigarette smoking remains the chief preventable cause of cardiovascular and pulmonary disease. While evidence-based treatments improve a smoker’s chances of quitting successfully, even with such treatments, the majority of smokers still fail to quit long-term in a given quit attempt. There is a clear need for more effective treatments. The proposed research would evaluate two treatment modifications that are designed to enhance the effectiveness of varenicline, an FDA-approved smoking cessation medication: 1) extending the duration of varenicline treatment; and 2) adding the nicotine mini-lozenge to varenicline to form a combined treatment. While existing data suggest that both modifications may substantially enhance varenicline effectiveness, neither has been adequately tested. The proposed research will use a 2X2 factorial design to randomize 1000 smokers to one of two levels of each of two factors: Duration (12- vs. 24-weeks of medication) and Adjuvant (varenicline + placebo lozenge vs. varenicline + nicotine mini-lozenge). Thus, smokers will receive either standard varenicline treatment (12 weeks of varenicline therapy) or 1 of 3 innovative, enhanced treatments: 12 weeks of varenicline + mini-lozenge, 24 weeks of extended treatment with varenicline only, or 24 weeks of extended treatment with varenicline + mini-lozenge. Analyses will reveal whether the Duration and Adjuvant modifications produce additive or interactive effects on smoking abstinence at 52 weeks postquit, the primary outcome. Also, planned comparisons will determine if any of the enhanced conditions is superior to standard varenicline therapy. The hypothesis is that 24-week duration and the mini-lozenge adjuvant will produce significant, additive main effects so that their combination (24-weeks of varenicline + mini-lozenge) produces higher abstinence rates at 52-weeks postquit than does standard 12-week varenicline treatment. Other outcomes include prolonged smoking abstinence, treatment cost-effectiveness, withdrawal suppression, and adverse events. In sum, this research is designed to produce an especially effective smoking cessation treatment that should increase the rate of pharmacologic intervention with smokers in healthcare, reduce smoking prevalence in patient populations, and reduce incidence of cardiovascular and pulmonary disease.