Testing Pharmacological Therapies for Pregnant Smokers

描述（由研究者提供）：妊娠期吸烟会导致严重 对胎儿和母亲的健康风险。大约一半的女性吸烟者继续 在怀孕期间吸烟。怀孕的妇女最难 戒烟，即使提供行为戒烟干预 倾向于更依赖尼古丁替代疗法的吸烟者 才能成功戒烟拟议的五年研究旨在 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），以促进吸烟 停止建议采用双臂设计。合格的孕妇（N=300）将 随机分配至：第1组，定制认知行为治疗（TCBT， n=150），为女性提供定制的吸烟风险信息， 尼古丁，对胎儿的潜在危害和鼓励适当的 行为技能建设;或第2组，TCBT + NRT -定制干预 包括NRT信息加上贴片或口香糖的选择（n约150）。的 干预措施将包括5次面对面接触，作为产前检查的一部分 两次电话咨询主要结局指标为 生物化学验证的19- 27日的7天普遍戒烟率， 怀孕27- 35周。次要结局将包括7天普遍 产后12周和24周的戒烟率，严重的戒烟尝试， 遵守NRT和使用材料。将测量唾液可替宁 在基线、妊娠第27- 35周和24周的所有妇女中， 产后这个项目的意义在于它依赖于 跨学科合作，扩展尼古丁替代科学 治疗人群，可以获得实质性的健康益处。 此外，研究结果有可能立即告知临床 建议将尼古丁替代纳入产前护理。

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.