Maternal Opioid Treatment: Human Experimental Research

母亲阿片类药物治疗：人体实验研究

• 批准号: 7442259
• 负责人: Sarah H Heil
• 金额: $ 46.08万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-24 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7442259
• 关键词: Abstinence; Abstinence Syndrome; Academic Medical Centers; Address; Agonist; All Sites; Appendix; Area; Austria; Baltimore; Behavioral; Biological; Biomedical Research; Birth; Blinded; Blood Chemical Analysis; Buprenorphine; Canada; Caring; Clinic; Clinical; Clinical Treatment; Clonidine; Collaborations; Commit; Communication; Communities; Complex; Comprehensive Health Care; Condition; Conduct Clinical Trials; Consent Forms; Controlled Clinical Trials; Daily; Data; Development; Discipline; Discipline of obstetrics; Disease; Doctor of Medicine; Doctor of Philosophy; Dose; Double-Blind Method; Drug Interactions; Drug Kinetics; Drug usage; Education; Elements; Ensure; Exhibits; Exposure to; Fetus; Future; Genetic; Gestational Age; Growth; Guidelines; Half-Life; Head circumference; Health; Health Care Costs; Heroin Dependence; Hospitalization; Hospitals; Housing; Human; Illicit Drugs; Incentives; Individual; Infant; Insurance; International; Intervention; Knowledge; Label; Lead; Legal; Length of Stay; Letters; Longitudinal Studies; Maintenance; Maryland; Measures; Medical; Medical Societies; Medicine; Mental Depression; Methadone; Methadyl Acetate; Methodology; Methods; Michigan; Morphine; Mothers; Names; National Institute of Drug Abuse; Neonatal; Neonatology; Newborn Infant; Nicotine; Numbers; Opiate Addiction; Opioid; Opium Tincture; Outcome; Outcome Measure; Pain; Parents; Participant; Patient Monitoring; Patient currently pregnant; Patients; Pediatrics; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Phenobarbital; Philadelphia; Physical Dependence; Physiological; Pilot Projects; Population; Population Study; Postpartum Period; Pregnancy; Pregnant Women; Principal Investigator; Procedures; Protocols documentation; Psychiatry; Public Policy; Purpose; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Regulation; Relative (related person); Research; Research Design; Research Ethics Committees; Research Infrastructure; Research Personnel; Resources; Rhode Island; Risk; Role; Safety; Science; Score; Sexual abuse; Signs and Symptoms; Site; Site Visit; Social Work; Societies; Stress Tests; Structure; Substance abuse problem; Surveys; System; Tennessee; Testing; Therapeutic; Time; Training; Transportation; Treatment Protocols; United States; United States Food and Drug Administration; Universities; University Hospitals; Ventilatory Depression; Vermont; Visit; Weaning; Week; Withdrawal; Woman; Work; addiction; base; blind; child protective service; college; day; design; desire; discounting; drug of abuse; experience; fetal; foster parent; improved; insight; interest; maternal drug abuse; medical complication; medical schools; medical specialties; methadone clinic/center; multidisciplinary; named group; neonate; opioid abuse; paregoric; probation; programs; psychosocial; quality assurance; research study; response; social; success; tool; volunteer; voucher

DESCRIPTION (provided by applicant): Though clearly beneficial, the use of methadone during pregnancy remains controversial due in part to the large l N percentage of newborns having signs of opioid withdrawal requiting 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 will be 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 proposes to participate in the multi-site trial lead by JHUSOM involving four other U.S. and two international sites. To do so, we have brought together a multidisciplinary team trained in psychiatry, addiction medicine, obstetrics, and neonatology with the professional expertise to provide comprehensive care for the participants and rigorous scientific expertise for the study. At the UVM site, opioid-dependent pregnant women will be randomized to optimal doses of methadone (n=24) or buprenorphine (n=24) 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; 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. Unique to the UVM site, delay discounting will be compared between study participants and gestational age matched community volunteers. The results of this site-specific study have the potential to provide important insights into why some pregnant women abuse opiates despite the potential harm that may do to the fetus. The UVM site has unique expertise, experience and resources 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.

描述（由申请人提供）： 尽管明显有益，但在怀孕期间使用美沙酮仍然存在争议，部分原因是很大比例的新生儿出现阿片类药物戒断迹象，需要医疗干预和延长住院时间。一种新药丁丙诺啡已获得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。] 来自双盲随机试验的有希望的初步数据约翰·霍普金斯大学医学院 (JHUSOM) 的研究表明，与美沙酮相比，丁丙诺啡可改善出生结局并减少新生儿戒断症状 (NAS)。目前的随机、平行组研究将是第一个评估丁丙诺啡相对于美沙酮在阿片类药物依赖孕妇中降低 NAS 疗效的多中心试验。佛蒙特大学 (UVM) 站点提议参加由 JHUSOM 牵头的多站点试验，涉及其他四个美国站点和两个国际站点。为此，我们聚集了一支在精神病学、成瘾医学、产科和新生儿学方面接受过培训的多学科团队，拥有专业知识，为参与者提供全面的护理，并为研究提供严格的科学专业知识。在 UVM 中心，阿片类药物依赖孕妇将被随机分配到最佳剂量的美沙酮 (n=24) 或丁丙诺啡 (n=24)，并在整个怀孕期间进行随访。将比较治疗组的 NAS 总评分峰值的主要结果指标；接受 NAS 治疗的新生儿数量；给予接受 NAS 治疗的新生儿的抗戒断药物总量；头围；和新生儿住院时间。次要新生儿/胎儿结局指标包括其他身体、行为和安全参数。次要产妇结局包括治疗保留、药物使用、用药安全、心理社会功能和剂量充足。 UVM 网站的独特之处在于，将对研究参与者和孕龄匹配的社区志愿者之间的延迟折扣进行比较。这项针对特定地点的研究结果有可能为为什么一些孕妇滥用阿片类药物（尽管可能对胎儿造成潜在伤害）提供重要见解。 UVM 站点拥有独特的专业知识、经验和资源，可以为这个新的潜在网络做出贡献，该网络旨在在难以招募的人群（即吸毒孕妇）中进行临床试验。总体而言，这项研究将为 FDA 提供关键数据，以支持在怀孕期间使用丁丙诺啡的适应症，并可能优化安全有效治疗阿片类药物依赖孕妇的策略。