A randomized trial of sertraline as a cessation aid for smokers with a history of major depression

A randomized trial of sertraline as a cessation aid for smokers with a history of major depression
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DOI:
10.1176/appi.ajp.159.10.1731
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发表时间:
2002-10-01
影响因子:
17.7
通讯作者:
Stage, K
Stage, K
中科院分区:
医学1区
文献类型:
--
作者:
Covey, LS;Glassman, AH;Stage, K

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目的:有证据表明,重度抑郁症可能是戒烟的一个重要障碍,这促使我们对舍曲林作为有重度抑郁症史的吸烟者戒烟辅助药物的有效性进行了研究。具体而言,舍曲林的戒烟效果和对戒断症状的影响进行了evaluated.Method:研究设计包括1周的安慰剂洗脱,9周的双盲,安慰剂对照的治疗阶段,随后由9天的锥度期,和6个月的无药随访。134名有严重抑郁症病史的吸烟者被随机分配接受舍曲林(N=68)或匹配的安慰剂(N=66);所有人在9次临床访视中接受了强化的个体戒烟咨询。然而,治疗组之间的戒烟率没有显著差异:在治疗结束时,安慰剂组为28.8%(66人中的19人),舍曲林组为33.8%(68人中的23人),在6个月随访时,安慰剂组为16.7%(66人中的11人),舍曲林组为11.8%(68人中的8人)。单一或复发性重性抑郁症,抑郁情绪在基线,尼古丁依赖水平,或gender observed.Conclusions:舍曲林没有增加的双盲,安慰剂对照研究中的一个密集的个人咨询计划的疗效。然而,鉴于安慰剂组治疗结束时的戒断率远高于预期,尚不清楚所有受试者接受的高水平心理干预的上限效应是否阻止了舍曲林的充分试验。
Objective: Evidence that major depression can be a significant hindrance to smoking cessation prompted this examination of the usefulness of sertraline as a cessation aid for smokers with a history of major depression. Specifically, sertraline's efficacy for smoking abstinence and its effects on withdrawal symptoms were evaluated.Method: The study design included a 1-week placebo washout, a 9-week double-blind, placebo-controlled treatment phase followed by a 9-day taper period, and a 6-month drug-free follow-up. one hundred thirty-four smokers with a history of major depression were randomly assigned to receive sertraline (N=68) or matching placebo (N=66); all received intensive individual cessation counseling during nine clinic visits.Results: Sertraline treatment produced a lower total withdrawal symptom score and less irritability, anxiety, craving, and restlessness than placebo. However, the abstinence rates did not significantly differ between treatment groups: 28.8% (19 of 66) for placebo and 33.8% (23 of 68) for sertraline at the end of treatment and 16.7% (11 of 66) for placebo and 11.8% (eight of 68) for sertraline at the 6-month follow-up. No moderating effects of single or recurrent major depression, depressed mood at baseline, nicotine dependence level, or gender were observed.Conclusions: Sertraline did not add to the efficacy of an intensive individual counseling program in a double-blind, placebo-controlled study. However, given that the end-of-treatment abstinence rate for the placebo group was much higher than expected, it is unclear whether a ceiling effect of the high level of psychological intervention received by all subjects prevented an adequate test of sertraline.