Testing Pharmacological Therapies for Pregnant Smokers

描述(由调查员提供)：怀孕期间吸烟构成严重后果 对胎儿和母亲的健康风险。大约一半的女性吸烟者继续吸烟 在怀孕期间吸烟。遇到最大困难的孕妇 即使提供了行为戒烟干预，也要戒烟 倾向于更依赖尼古丁替代疗法的吸烟者 成功戒烟。拟议的为期五年的研究旨在 评估提供非处方(OTC)尼古丁的有效性 替代疗法，选择口香糖或贴片(NRT)以促进产前吸烟 停止。提出了一种双臂设计。符合条件的孕妇(N=300)将 随机分为两组：组1，量身定制的认知行为治疗(TCBT， N=150)，为女性提供有关吸烟的定制风险信息 尼古丁对胎儿的潜在危害及适当的鼓励 行为技能培养；或ARM 2，TCBT+NRT-量身定制的干预 结合NRT信息以及贴片或口香糖的选择(n约150)。这个 干预措施将包括5次面对面的接触，作为产前访问的一部分 和两次电话咨询。主要结果衡量标准将是 经过生化验证的19-27天的7天普遍禁酒率和 怀孕27-35周。次要结果将包括7天流行 产后12周和24周的禁酒率，严重的戒烟尝试， 遵守NRT，并使用材料。唾液中的可替宁将被测量 在所有处于基线的妇女中，怀孕27-35周和24周 产后。这个项目的意义在于它依赖于 跨学科合作以扩展尼古丁替代科学 对人群的治疗可能会带来实质性的健康益处。 此外，研究结果立即有可能为临床提供信息。 将尼古丁替代纳入产前护理的建议。

DESCRIPTION (provided by investigator): Smoking in pregnancy poses serious health risks to the fetus and the mother. About half of women smokers continue to smoke throughout pregnancy. Pregnant women who have the greatest difficulty quitting smoking even when provided with behavioral cessation interventions tend to be more dependent smokers who may requite nicotine replacement therapy to be successful at cessation. The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum or patch, (NRT) to promote prepartum smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=150) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n about150). The intervention will include 5 face-to-face contacts as part of prenatal visits and 2 telephone counseling sessions. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 27-35th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 and 24 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 24 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care.