Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch.
Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch.
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DOI：
10.1016/j.drugalcdep.2010.04.021
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发表时间：
2010-11-01
影响因子：
4.2
通讯作者：
O'Malley SS
中科院分区：
文献类型：
--
作者：
Epperson CN;Toll B;Wu R;Amin Z;Czarkowski KA;Jatlow P;Mazure CM;O'Malley SS
在一系列探索性分析中，我们研究了性别、生殖状态和负面影响对参与尼古丁贴片治疗的大型（n=385）6周随机临床试验（RCT）的受试者戒烟的作用，其中口服不同剂量的纳洛酮（0 mg，25 mg，50 mg，100 mg）治疗。在戒烟后的第一周，每天通过电话交互式语音应答（IVR）评估负面情绪。每周记录体重和不良事件。在意向治疗样本中，在男性和女性的总体模型中，剂量对持续戒烟的影响不显著。在295例研究完成者中，仅女性的剂量对持续戒烟有显著影响（F=8.53，p=0.04）。在100 mg组中，71%的女性持续禁欲，而安慰剂组为41%（p<0.05）。积极纳洛酮组的女性体重增加较少（F=2.91，df=3，p=0.04）。与安慰剂组相比，100 mg组的妇女对药物的依从性较低（F=3.19，p<0.05）。这些影响在男性中并不显著。纳洛酮治疗条件（100 mg vs安慰剂，p=0.02，比值比（OR）=0.28）、性别（OR=0.55，p=0.09）和IVR负面情绪评级（OR 1.02，p=0.04）可预测研究完成者在第-1周的戒断。戒烟日月经周期状况对禁欲有一定影响。这些数据表明，纳洛酮剂量，性别和负面影响在戒烟中发挥作用，特别是在治疗的早期阶段。当与尼古丁替代疗法结合使用时，纳洛酮剂量可能对女性很重要。
In a series of exploratory analyses, we examined the roles of gender, reproductive status and negative affect on smoking abstinence in subjects participating in a large (n=385) 6-week randomized clinical trial (RCT) of nicotine patch therapy, with varying doses of oral naltrexone (0 mg, 25 mg, 50 mg, 100 mg) treatment. Negative affect was assessed daily during the first post-quit week via telephone interactive voice response (IVR). Weight and adverse events were recorded weekly. In the intent to treat sample, the effects of dose on continuous abstinence were non-significant in the overall model for men and women. In the 295 study completers, there was a significant effect of dose on continuous abstinence in women only (F=8.53, p=0.04). In the 100 mg group, 71% of women were continuously abstinent compared to 41% in the placebo group (p<0.05). Women in the active naltrexone groups gained less weight (F=2.91, df=3, p=0.04). Women in the 100 mg versus placebo group were less adherent with medication (F=3.19, p<0.05). These effects were not significant in men. Naltrexone treatment condition (100 mg vs placebo, p=0.02, odds ratio (OR)=0.28), gender (OR=0.55 p=0.09), and IVR ratings of negative affect (OR 1.02, p=0.04) predicted abstinence at Week-1 in study completers. Menstrual cycle status on quit day had a modest affect on abstinence. These data suggest that naltrexone dose, gender, and negative affect play a role in smoking abstinence, particularly in the early stages of treatment. When used in conjunction with nicotine replacement therapy, naltrexone dose may be important in women.
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