Maternal Opioid Treatment: Human Experimental Research

尽管美沙酮显然是有益的，但在怀孕期间使用美沙酮仍然存在争议，部分原因是 有阿片类药物戒断迹象的新生儿需要医疗干预和延长住院时间。一种新的 丁丙诺啡被美国食品和药物管理局(FDA)批准用于治疗非怀孕患者 阿片类药物依赖患者，在突然戒断后只会产生轻度戒断综合征。前景看好 来自约翰霍普金斯医学院(JHUSOM)的双盲随机试验的初步数据显示 直接获知这项修订后的申请，并建议丁丙诺啡可改善分娩结局并减少 与美沙酮相关的新生儿戒断综合征(NAS)。目前的随机、平行分组研究将是 首次多点试验评估丁丙诺啡对阿片依赖孕妇减少NAS的效果 相对于美沙酮。JHUSOM是这项研究的牵头站点，涉及六个美国站点和两个国际站点。 JHUSOM团队接受了成瘾药物、精神病学、儿科、产科、新生儿学的培训，并控制了 临床试验将确保该研究的全面监督和严格的科学完整性。阿片依赖 孕妇将被随机分配到最佳剂量的美沙酮(n=30)或丁丙诺啡(n=30)，并跟踪 在整个怀孕期间。比较两组治疗前后NAS总分峰值的主要预后指标； 接受NAS治疗的新生儿数量；为接受NAS治疗的新生儿给予的抗戒断药物总量； 头围出生体征参数；新生儿住院时间。继发性新生儿/胎儿结局 措施包括其他物理、行为和安全参数。次要产妇结局包括治疗 留存、药物使用、用药安全性、心理社会功能和剂量充分性。这第一项研究将建立一个 在进行药物治疗的对照试验方面具有专业知识的基础设施和网络 1怀孕/依赖的孕妇。总体而言，这项研究将为FDA提供关键数据，以支持一种适应症 在妊娠期使用丁丙诺啡，并可能优化安全有效的治疗策略 我不知道这是什么意思。

Though clearly beneficial, the use of methadone during pregnancy remains controversial 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) have informed directly this revised application and suggest that buprenorphine results in improved birth outcomes and less neonatal abstinence syndrome (NAS) relative to methadone. The current randomized, parallel group study will be the first multi-site trial to assess in opioid-dependent pregnant women the efficacy of buprenorphine for reducing NAS relative to methadone. JHUSOM is the Lead Site for this study involving six United States and two international sites. The JHUSOM team trained in addiction medicine, psychiatry, pediatrics, obstetrics, neonatology, and controlled clinical trials will assure comprehensive oversight and rigorous scientific integrity of the study. Opioid-dependent pregnant women will be randomized to optimal doses of methadone (n=30) or buprenorphine (n=30) and followed throughout pregnancy. 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; physical birth parameter of 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. This first study will establish an Lnfrastructure and network with expertise in conducting controlled trials with pharmacotherapies for substance 1busing/dependent pregnant women. Overall, this study will provide pivotal data to the FDA to support an indication for the use ofbuprenorphine during pregnancy and potentially optimize strategies for safe and effective treatment of nrepnant nninid-denendent wnmen.