Sequential Use of Fluoxetine for Smokers with Elevated Depressive Symptoms

描述(由申请人提供)：吸烟者抑郁症状的增加与戒烟失败有可靠的联系。虽然几种抗抑郁药物已经证明了戒烟的有效性，但氟西汀在治疗抑郁症状水平升高的吸烟者方面表现出了特别的前景。我们最近完成了一项氟西汀治疗抑郁症状升高的吸烟者的随机临床试验，发现与同时使用氟西汀相比，连续使用氟西汀(从戒烟日期前8周开始)可以产生更好的戒烟效果。然而，我们先前研究设计的一个局限性是，我们不能排除我们的发现可能是由于安慰剂效应或额外接触时间的影响。因此，在临床实践中推广这一方法之前，我们认为首先确定这是否是氟西汀的积极药理作用是至关重要的。这项拟议的研究是一项随机、双盲、安慰剂对照的氟西汀试验，与我们早期的研究一样按顺序使用。这项试验旨在检验这一基本假设，即在206名抑郁症状升高的吸烟者(CESD&GT；6)中，序贯抗抑郁药物治疗与(20 mg。)根据相同的治疗计划，氟西汀(FLUOXSEQ)在短暂的标准尼古丁贴片(ST-TNP)戒烟治疗前8周开始并一直延伸到整个治疗过程，与安慰剂药物(PLAC-SEQ)和ST-TNP相结合的顺序药物疗法相比，将产生更好的戒烟效果。吸烟结果将在整个治疗过程中以及在2、6和12个月的随访中进行评估。将评估当前和过去的精神诊断，以及抑郁症状、尼古丁戒断症状和相关情绪状态的变化。

DESCRIPTION (provided by applicant): Elevated depressive symptoms in smokers has reliably been associated with smoking cessation failure. While several antidepressant medications have demonstrated efficacy for smoking cessation, fluoxetine has specifically shown promise in the treatment of smokers with elevated levels of depressive symptoms. We recently completed a randomized clinical trial of fluoxetine for smokers with elevated depressive symptoms, and found that sequential use of fluoxetine (starting 8 weeks prior to quit date) resulted in superior smoking cessation outcomes compared to concurrent use of fluoxetine. However, one limitation of our prior study design is that we could not rule out the possibility that our findings may have been due to placebo effects or the effects of additional contact time. Therefore, before disseminating this approach in clinical practice settings, we believe that it is critical to first determine whether this is an active pharmacologic effect of fluoxetine. The proposed study is a randomized, double-blind, placebo controlled trial of fluoxetine, used sequentially as in our earlier study. This trial is intended to test the primary hypothesis that among 206 smokers with elevated depressive symptoms (CESD > 6), sequential antidepressant pharmacotherapy with (20 mg.) fluoxetine (FLUOXSEQ), begun 8 weeks prior to and extended throughout brief standard smoking cessation treatment with transdermal nicotine patch (ST-TNP), will result in superior smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication (PLAC-SEQ) combined with ST-TNP, according to the identical treatment schedule. Smoking outcomes will be assessed throughout treatment and at 2-, 6- and 12-month follow-ups. Current and past psychiatric diagnoses will be assessed, as will changes in depressive symptoms, nicotine withdrawal symptoms and associated mood states.