CLINICAL TRIAL: MOTHER

临床试验：母亲

• 批准号: 7952101
• 负责人: Sarah H Heil
• 金额: $ 11.84万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952101
• 关键词: Abstinence; Abstinence Syndrome; Admission activity; Behavioral; Birth; Buprenorphine; Clinic; Clinical Research; Clinical Trials; Comprehensive Health Care; Computer Retrieval of Information on Scientific Projects Database; Conduct Clinical Trials; Data; Discipline of obstetrics; Dose; Double-Blind Method; Drug usage; Eligibility Determination; Funding; Grant; Head circumference; Hospitalization; Inpatients; Institution; International; Intervention; Lead; Length of Stay; Medical; Medicine; Methadone; Mothers; Neonatal; Neonatology; Newborn Infant; Opioid; Outcome; Outcome Measure; Outpatients; Participant; Patients; Pharmaceutical Preparations; Population; Pregnancy; Pregnant Women; Psychiatry; Randomized; Randomized Controlled Clinical Trials; Recruitment Activity; Relative (related person); Research; Research Methodology; Research Personnel; Resources; Safety; Services; Site; Source; Training; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vermont; Withdrawal; Woman; addiction; design; effective therapy; experience; fetal; improved; medical schools; multi-site trial; multidisciplinary; neonate; opioid withdrawal; pregnant; primary outcome; psychosocial

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. Though clearly beneficial, the use of methadone during pregnancy remains controversial due in part to the large percentage of newborns having signs of opioid withdrawal requiring medical intervention and extended hospitalization. A new medication, buprenorphine, is approved by the Food and Drug Administration (FDA) for the treatment of non-pregnant opioid-dependent patients and produces only a mild abstinence syndrome following abrupt withdrawal. Promising preliminary data from a double-blind randomized trial at the Johns Hopkins School of Medicine (JHUSOM) suggest that buprenorphine results in improved birth outcomes and fewer neonatal abstinence signs (NAS) relative to methadone. The current randomized, parallel group study is the first multi-site trial to assess the efficacy of buprenorphine for reducing NAS relative to methadone in opioid-dependent pregnant women. The University of Vermont (UVM) site will participate in the multi-site trial lead by JHUSOM along with four other U.S. and two international sites. To do so, we have brought together a multidisciplinary team trained in psychiatry, addiction medicine, obstetrics, neonatology and research methodology with the professional expertise to provide comprehensive care for the participants and rigorous scientific expertise to conduct the study. Opioid-dependent pregnant women at the UVM site will be admitted to our General Clinical Research Center (GCRC) for approximately three days to be screened for eligibility. Those eligible to participate will be randomized to receive either methadone (n=24) or buprenorphine (n=24). Induction onto double-blind, double-dummy study medications will also occur as inpatient admissions to the GCRC for approximately another three days to provide rigorous scientific control and maximize participant safety. For the remainder of the study, medication administration and other treatment services will occur at our outpatient treatment clinic. Participants will be followed throughout pregnancy and treatment groups will be compared on the primary outcome measures of peak total NAS score; number of neonates treated for NAS; total amount of anti-withdrawal medication given to neonates treated for NAS; head circumference; and neonatal length of hospital stay. Secondary neonatal/fetal outcome measures include other physical, behavioral and safety parameters. Secondary maternal outcomes include treatment retention, drug use, medication safety, psychosocial functioning and dose adequacy. The UVM site has unique expertise, experience, facilities and resources, including the GCRC, to contribute to this new potential network designed to conduct clinical trials in a difficult to recruit population (i.e., drug-abusing pregnant women). Overall, this study will provide pivotal data to the FDA to support an indication for the use of buprenorphine during pregnancy and potentially optimize strategies for safe and effective treatment of pregnant opioid-dependent women.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 虽然明显有益，但在怀孕期间使用美沙酮仍然存在争议，部分原因是新生儿有阿片类药物戒断的迹象，需要医疗干预和延长住院时间。一种新的药物丁丙诺啡被美国食品和药物管理局（FDA）批准用于治疗非妊娠阿片类药物依赖患者，并且在突然停药后仅产生轻度戒断综合征。 来自约翰霍普金斯医学院（JHUSOM）的一项双盲随机试验的有希望的初步数据表明，与美沙酮相比，丁丙诺啡可改善出生结局，减少新生儿戒断体征（NAS）。目前的随机化，平行组研究是第一个多中心试验，以评估丁丙诺啡相对于美沙酮在阿片类药物依赖的孕妇中减少NAS的疗效。 佛蒙特大学（UVM）研究中心将与其他四个美国和两个国际研究中心一起参与由JHUSOM沿着领导的多中心试验。 为此，我们汇集了一个多学科团队，他们在精神病学，成瘾医学，产科，妇科学和研究方法学方面接受了培训，具有专业知识，为参与者提供全面的护理，并拥有严格的科学知识来进行研究。 UVM研究中心的阿片类药物依赖妊娠女性将在我们的综合临床研究中心（GCRC）住院约3天，以筛选合格性。 有资格参与的患者将随机接受美沙酮（n=24）或丁丙诺啡（n=24）。还将在GCRC住院约3天时诱导接受双盲、双模拟研究药物，以提供严格的科学控制并最大限度地提高受试者的安全性。 对于研究的剩余时间，药物给药和其他治疗服务将在我们的门诊治疗诊所进行。 将在整个妊娠期间对参与者进行随访，并比较治疗组的主要结局指标：峰值总NAS评分;接受NAS治疗的新生儿数量;接受NAS治疗的新生儿的抗戒断药物总量;头围;新生儿住院时间。 次级新生儿/胎儿结局指标包括其他身体、行为和安全参数。次要孕产妇结局包括治疗保留、药物使用、药物安全性、心理社会功能和剂量充足性。 UVM研究中心拥有独特的专业知识、经验、设施和资源，包括GCRC，可为这一新的潜在网络做出贡献，该网络旨在在难以招募的人群中开展临床试验（即，吸毒孕妇）。总体而言，这项研究将为FDA提供关键数据，以支持妊娠期间使用丁丙诺啡的适应症，并可能优化安全有效治疗妊娠阿片类药物依赖女性的策略。