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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 尽管显然有益，但在怀孕期间使用美沙酮仍存在争议，部分原因是大部分新生儿具有需要医疗干预和扩大住院治疗的阿片类药物戒断迹象。食品药品监督管理局（FDA）批准了一种新的药物，丁丙诺啡，用于治疗非妊娠阿片类药物依赖性患者，并在突然戒断后仅产生轻度的戒毒综合症。 约翰·霍普金斯医学院（Jhusom）的双盲随机试验中有希望的初步数据表明，丁丙诺啡可改善出生结果，而相对于美沙酮，相对于美沙酮，丁丙诺啡可改善出生结果，而新生儿的禁欲迹象（NAS）较少。当前的随机，平行组研究是评估丁丙诺啡在阿片类药物依赖性孕妇中减少NAS相对于美沙酮的疗效​​的第一项多站点试验。 佛蒙特大学（UVM）网站将与Jhusom一起参加多站点的试验，以及其他四个美国和两个国际地点。 为此，我们将一个跨学科的团队汇集在一起​​，该团队接受了精神病学，成瘾医学，妇产科，新生儿学和研究方法的培训，并提供了专业知识，以为参与者提供全面的护理，并进行严格的科学专业知识来进行研究。 UVM部位的阿片类药物依赖性孕妇将被送往我们的一般临床研究中心（GCRC）约三天，以筛选资格。 符合参与的人将被随机地接收美沙酮（n = 24）或丁丙诺啡（n = 24）。对双盲双盲研究药物的诱导也将作为对GCRC的住院入院大约三天，以提供严格的科学控制并最大化参与者的安全性。 在研究的其余部分中，我们的门诊治疗诊所将发生药物施用和其他治疗服务。 将在整个怀孕期间遵循参与者，并将治疗组与NAS峰值总分的主要结果度量进行比较； NAS治疗的新生儿数量；给予NAS治疗的新生儿的抗WithDrawal药物的总量；头围；和新生儿住院时间。 次级新生儿/胎儿结局指标包括其他物理，行为和安全参数。次要母亲结果包括保留治疗，药物使用，药物安全，社会心理功能和剂量是否足够。 UVM网站具有独特的专业知识，经验，设施和资源，包括GCRC，为这个新的潜在网络做出贡献，旨在在难以招募的人群（即滥用毒品的孕妇）中进行临床试验。总体而言，这项研究将向FDA提供关键数据，以支持怀孕期间使用丁丙诺啡的指示，并有可能优化策略，以安全有效地治疗怀孕的阿片类药物依赖性妇女。