Sequential Use of Fluoxetine for Smokers with Elevated Depressive Symptoms

抑郁症状加重的吸烟者序贯使用氟西汀

• 批准号: 7643206
• 负责人: RICHARD A BROWN
• 金额: $ 59.16万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-28 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7643206
• 关键词: Affect; Aftercare; American Cancer Society; Antidepressive Agents; Clinical; Clinical Trials; Diagnostic; Enrollment; Failure; Fluoxetine; Funding; Future; Healthcare; Knowledge; Major Depressive Disorder; Mediating; Mental Depression; Moods; Morbidity - disease rate; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebo Effect; Placebos; Prevalence; Primary Health Care; Psychiatric Diagnosis; Public Health; Randomized; Randomized Clinical Trials; Relative (related person); Research; Research Design; Research Project Grants; Risk; Risk Factors; Sampling; Selective Serotonin Reuptake Inhibitor; Sequential Treatment; Smoke; Smoker; Smoking; Testing; Time; Treatment Protocols; Withdrawal Symptom; Withholding Treatment; alternative treatment; cigarette smoking; clinical practice; depressive symptoms; design; double-blind placebo controlled trial; human PTCH2 protein; improved; interest; meetings; mortality; negative mood; nicotine patch; positive mood; programs; smoking cessation; time use

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.

描述（由申请人提供）：吸烟者抑郁症状加重已可靠地与戒烟失败相关。虽然几种抗抑郁药物已被证明对戒烟有效，但氟西汀在治疗抑郁症状严重的吸烟者方面尤其显示出希望。我们最近完成了一项针对抑郁症状加重的吸烟者的氟西汀随机临床试验，发现与同时使用氟西汀相比，连续使用氟西汀（戒烟日期前 8 周开始）可产生更好的戒烟结果。然而，我们之前的研究设计的一个局限性是，我们不能排除我们的研究结果可能是由于安慰剂效应或额外接触时间的影响的可能性。因此，在临床实践中传播这种方法之前，我们认为首先确定这是否是氟西汀的活性药理作用至关重要。拟议的研究是一项氟西汀的随机、双盲、安慰剂对照试验，与我们早期的研究一样按顺序使用。本试验旨在检验主要假设，即在 206 名抑郁症状加重的吸烟者 (CESD > 6) 中，序贯抗抑郁药物治疗 (20 mg.) 氟西汀 (FLUOXSEQ) 在使用透皮尼古丁贴片 (ST-TNP) 的短暂标准戒烟治疗前 8 周开始并持续进行，与序贯药物治疗相比，将产生更好的戒烟结果。 根据相同的治疗方案，安慰剂药物（PLAC-SEQ）与 ST-TNP 联合使用。将在整个治疗过程以及 2、6 和 12 个月的随访中评估吸烟结果。将评估当前和过去的精神病诊断，以及抑郁症状、尼古丁戒断症状和相关情绪状态的变化。