Nicotine Replacement Treatment for Pregnant Smokers

描述：（申请人提供） 在怀孕期间吸烟是导致贫困的最重要的可改变的原因之一。 美国的妊娠结局。不幸的是，大多数女性 怀孕前吸烟的人在怀孕期间继续吸烟。即使有 增强行为干预，妊娠试验中的戒烟率 很少超过20%。这些低戒烟率可能是由于不充分的 尼古丁成瘾的治疗事实上，药物 非妊娠吸烟者吸烟治疗的一线治疗。然而，在这方面， 关于药物的安全性或有效性的信息很少， 治疗怀孕的吸烟者。本提案将审查一个 一线药物，尼古丁口香糖，作为戒烟的辅助手段， 怀孕本课题的具体研究目标是：1.比较 怀孕吸烟者的戒烟率和吸烟减少率 随机接受2 mg尼古丁口香糖或匹配的安慰剂; 2.比较 尼古丁咀嚼胶与安慰剂对母体和胎儿安全性替代指标的影响 (i.e.,总尼古丁和烟草暴露），以及出生时的体重 交付; 3.研究哪些受试者从使用 尼古丁口香糖在怀孕期间戒烟。 受试者将从产前诊所招募，该诊所主要提供 低收入的少数民族266名怀孕的吸烟者， 每天吸烟最少5支者将被随机分配到 行为咨询干预和2 mg尼古丁的6周疗程 口香糖或安慰剂戒烟，然后6周逐渐减少。初级 结果测量将是7天时点戒烟率、 每天吸烟，唾液可替宁浓度，以及测量 烟草暴露（即，呼出空气中的一氧化碳，以及尿液中的假木贼碱， anatabine）在戒烟日期后6周和妊娠32-34周。出生 重量将在交货时获得。我们假设1。 怀孕的吸烟者被随机分配到尼古丁口香糖组， 率，并将减少他们的吸烟到更大的程度比受试者 随机分配至安慰剂; 2.与安慰剂相比，尼古丁口香糖将减少孕产妇死亡率 可替宁水平，碳氧血红蛋白水平，以及尿液中的假木贼碱和新烟草碱 程度.随机分配至以下组的受试者的后代的出生体重将更高： 尼古丁口香糖与安慰剂相比， 妊娠32-34周时的一氧化物和尿生物碱; 3.的几率 戒烟率将主要在吸烟至少 每天15支烟。

DESCRIPTION: (provided by applicant) Smoking during pregnancy is one of the most important modifiable causes of poor pregnancy outcomes in the United States. Unfortunately, the majority of women who smoke prior to pregnancy continue to smoke during pregnancy. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20 percent. These low quit rates may be due to inadequate treatment of the physical addiction to nicotine. Indeed, medications are first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers. This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy. The specific research aims of this project are: 1. To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive 2 mg nicotine gum or a matching placebo; 2. To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety (i.e., overall nicotine and tobacco exposure), and birth weight at the time of delivery; 3. To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy. Subjects will be recruited from a prenatal clinic that serves primarily a low-income, minority population. Two hundred sixty-six pregnant smokers who smoke at least 5 cigarettes per day will be randomly assigned to receive a behavioral counseling intervention and either a 6-week course of 2 mg nicotine gum or placebo for smoking cessation followed by a 6-week taper. Primary outcome measures will be 7-day point prevalence cigarette abstinence, number of cigarettes smoked per day, saliva cotinine concentrations, and measures of tobacco exposure (i.e., carbon monoxide in exhaled air, and urine anabasine and anatabine) at 6 weeks after the quit date and at 32-34 weeks gestation. Birth weight will be obtained at the time of delivery. We hypothesize that 1. Pregnant smokers who are randomized to nicotine gum will have double the quit rates, and will reduce their smoking to a greater degree than subjects randomized to placebo; 2. Nicotine gum compared to placebo will reduce maternal cotinine levels, carboxyhemoglobin levels, and urine anabasine and anatabine levels. Birth weights will be higher in the offspring of subjects randomized to nicotine gum compared to placebo and will be negatively correlated with carbon monoxide and urinary alkaloids at 32-34 weeks gestation; 3. The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day.