CLINICAL TRIAL: NICOTINE REPLACEMENT TREATMENT (SNAP)NICOTINE REPLACEMENT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 虽然药物是成人戒烟的一线治疗方法(1)，30%-40%的产科医生在怀孕期间开出或推荐非处方药尼古丁替代疗法戒烟(2，3)，但怀孕吸烟者几乎没有关于这些产品的有效性或安全性的信息。我们提出了一项随机、安慰剂对照的临床试验，以评估尼古丁口香糖在妊娠期戒烟的有效性。这项试验的受试者将从康涅狄格州哈特福德的一家大型产前诊所招募。这家诊所为吸烟率为29%的贫困人口提供服务。除了测试干预的有效性和安全性外，我们还将检查女性反应的预测因素，并对可能增加吸烟对胎儿不利影响的母亲遗传因素进行分析。 这项研究的具体目的是：比较尼古丁口香糖和与之匹配的安慰剂在怀孕吸烟者中戒烟的效果。检查尼古丁和安慰剂口香糖是否减少怀孕吸烟者每天吸烟的数量；评估尼古丁口香糖在怀孕期间戒烟的安全性。具体地说，我们将比较尼古丁口香糖和安慰剂在总尼古丁暴露(以唾液可替宁衡量)、总烟草暴露(以呼出的一氧化碳和尿生物碱衡量)以及分娩时出生体重方面的差异；确定决定哪些受试者从怀孕期间使用尼古丁替代疗法戒烟中受益最大的因素；并在不同种族的怀孕吸烟者样本中检查母亲吸烟与两个基因座(CYP1A1和GSTT1)等位基因变异对出生体重的影响。作为一个探索性的目的，我们还将评估戒烟与其他选定的药物代谢相I和II期基因对出生体重的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Although medications are first-line treatment for smoking cessation in adults (1), and 30-40% of obstetricians prescribe or recommend over-the-counter nicotine replacement therapies for smoking cessation during pregnancy (2,3), little information on the efficacy or safety of these products is available for pregnant smokers. We propose a randomized, placebo-controlled, clinical trial to assess the utility of nicotine gum for smoking cessation during pregnancy. Subjects for this trial will be recruited from a large prenatal clinic in Hartford, Connecticut. This clinic serves an indigent population with a smoking rate of 29%. In addition to testing the efficacy and safety of the intervention, we will examine predictors of response among the women and we will conduct an analysis of maternal genetic factors that can augment the adverse effects of smoking on the fetus. The specific aims of this study are: to compare the efficacy of nicotine gum or a matching placebo for smoking cessation among pregnant smokers. To examine whether nicotine versus placebo gum reduces the number of cigarettes smoked per day by pregnant smoker; to evaluate the safety of nicotine gum for smoking cessation during pregnancy. Specifically, we will compare nicotine gum with placebo on overall nicotine exposure (as measured by salivary cotinine), overall tobacco exposure (as measured by exhaled carbon monoxide and urinary alkaloids), and birth weight at the time of delivery; to identify factors that determine which subjects benefit the most from the use of nicotine replacement therapy for smoking cessation during pregnancy; and to examine the interaction between maternal smoking and allelic variation at two genetic loci (CYP1A1 and GSTT1) on birth weight in a racially diverse sample of pregnant smokers. As an exploratory aim we will also evaluate the interaction between smoking cessation and allele variations of other selected phase I and II genes of drug metabolism on birth weight.