NICOTINE REPLACEMENT TREATMENT (SNAP)NICOTINE REPLACEMENT

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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处方或推荐非处方尼古丁替代疗法（2,3），但关于这些产品对怀孕吸烟者的有效性或安全性的信息很少。我们建议进行一项随机、安慰剂对照的临床试验，以评估尼古丁口香糖在怀孕期间戒烟的效用。本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。这家诊所服务的是吸烟率为29%的贫困人口。除了测试干预措施的有效性和安全性外，我们还将检查妇女反应的预测因素，并对母体遗传因素进行分析，这些因素可能会增加吸烟对胎儿的不利影响。这项研究的具体目的是：比较尼古丁口香糖或相匹配的安慰剂对怀孕吸烟者戒烟的效果。研究尼古丁与安慰剂口香糖是否能减少怀孕吸烟者每天吸烟的数量；评价尼古丁口香糖用于妊娠期戒烟的安全性。具体来说，我们将比较尼古丁口香糖与安慰剂的总体尼古丁暴露（通过唾液可替宁测量），总体烟草暴露（通过呼出的一氧化碳和尿液生物碱测量）和分娩时的出生体重；确定哪些受试者在怀孕期间使用尼古丁替代疗法戒烟获益最大的因素；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位点（CYP1A1和GSTT1）的等位基因变异之间的相互作用。作为一个探索性目的，我们还将评估戒烟与其他选定的药物代谢I期和II期基因等位基因变异对出生体重的相互作用。

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.