Testing Pharmacological Therapies for Pregnant Smokers

测试怀孕吸烟者的药物治疗

• 批准号: 6435371
• 负责人: COLLEEN M MC BRIDE
• 金额: $ 65.46万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6435371
• 关键词: behavioral /social science research tag; clinical research; cognitive behavior therapy; disease /disorder proneness /risk; drug screening /evaluation; embryo /fetus toxicology; human therapy evaluation; longitudinal human study; nicotine replacement; outcomes research; patient oriented research; placental transfer; pregnancy; prenatal care; saliva; smoking; tobacco abuse; vertical transmission; women's health

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.

描述（调查员提供）：怀孕的吸烟严重 胎儿和母亲的健康风险。大约一半的女性吸烟者继续 在整个怀孕期间吸烟。孕妇有最大的困难 即使得到行为停止干预措施，也要戒烟 往往是更依赖的吸烟者，他们可能需要尼古丁替代疗法 成功停止。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，口香糖或斑块的选择，（NRT）以促进产前吸烟 停止。提议是两臂设计。合格的孕妇（n = 300）将 随机分配到：ARM 1，量身定制的认知行为治疗（TCBT， n = 150）为妇女提供有关吸烟和的定制风险信息 尼古丁，对胎儿的潜在伤害和鼓励 行为技能建设；或ARM 2，TCBT + NRT-量身定制的干预 合并NRT信息加上斑块或口香糖的选择（n大约150）。这 干预将包括5个面对面联系人作为产前访问的一部分 和2次电话咨询会议。主要结果指标将是 生化验证了19-27和 怀孕第27-35周。次要结果将包括7天的流行 产后12和24周的禁欲率，严重的戒烟尝试， 符合NRT和材料的使用。唾液可替宁将被测量 在基线的所有妇女中，怀孕的第27-35周和24周 产后。该项目的意义在于它依靠 跨学科合作，以扩展尼古丁替代的科学 对人群的疗法，可以获得可观的健康益处。 此外，研究结果具有直接的潜力，可以告知临床 将尼古丁替代替换为产前护理的建议。