Enhancing the Effectiveness of Varenicline Based Smoking Cessation Treatment

项目概要/摘要 吸烟仍然是心血管和肺血管疾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。 企图。显然需要更有效的治疗方法。拟议的研究将 评估两种治疗方法的改进，旨在提高 伐尼克兰，FDA批准的戒烟药物：1）延长持续时间 伐尼克兰治疗;和2）将尼古丁微型锭剂加入伐尼克兰中以形成组合的 治疗虽然现有的数据表明，这两种修改可能会大大提高 伐尼克兰的有效性，也没有得到充分的测试。该研究将使用一个 2X2析因设计，将1000名吸烟者随机分配至两个因素的两个水平之一： 持续时间（用药12周vs. 24周）和辅助治疗（伐尼克兰+安慰剂含片vs. 伐尼克兰+尼古丁微型锭剂）。因此，吸烟者将接受标准伐尼克兰 治疗（12周伐尼克兰治疗）或3种创新强化治疗之一：12 伐尼克兰+迷你含片治疗24周，仅用伐尼克兰延长治疗24周，或 24周的伐尼克兰+迷你含片扩展治疗。分析将揭示， 持续时间和辅助剂的改变对吸烟产生累加或交互作用 戒烟后52周的戒烟率，主要结果。此外，计划中的比较将 确定是否有任何增强条件上级标准伐尼克兰治疗。的 假设是24周持续时间和小锭剂佐剂将产生显著的， 主效应相加，因此其联合用药（24周伐尼克兰+迷你含片） 在戒烟后52周， 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。总之，这项研究旨在产生一个 特别有效的戒烟治疗，应增加药物治疗的比率， 在医疗保健中对吸烟者进行干预，降低患者人群的吸烟率，以及 降低心血管和肺部疾病的发病率。

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.