Buprenorphine Treatment of Neonatal Abstinence Syndrome

丁丙诺啡治疗新生儿戒断综合症

基本信息

批准号：
7117376
负责人：
WALTER K KRAFT
金额：
$ 13.53万
依托单位：
THOMAS JEFFERSON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-01 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7117376
关键词：
buprenorphine clinical research comorbidity drug abuse chemotherapy drug addiction drug screening /evaluation drug withdrawal human subject infant human (0-1 year)morphine opiate alkaloid patient oriented research pharmacokinetics

项目摘要

DESCRIPTION (provided by applicant): Neonatal abstinence syndrome (NAS) is diagnosed in 55-94% or infants born to opioid-dependent mothers (American Academy of Pediatrics Committee on Drugs, 1998), and approximately 7000 at-risk infants are born in the United States each year (National Pregnancy and Health Survey, 1996). It is estimated that 2.8% of pregnant women use illicit drugs, and the problem is of course even larger when considered internationally. Hospitalization time for otherwise-healthy treated infants is prolonged, lasting from several weeks up to two months, which is a burden on both the parent and infant, and has a large financial impact. There is a need for improved treatment options. Simplistically, from the neonatal aspect of NAS, goals would include to safely decrease its incidence, severity, and duration, and thereby decrease the hospitalization time (and simultaneous separation from the parents) and exposure to other medications. Due to its partial mu opioid receptor agonist activity, high receptor affinity, and low intrinsic opioid activity, the pharmacological profile of buprenorphine greatly differs from that of methadone, the most widely used treatment for the mothers, and from that of morphine, one of the most widely used medical treatments for NAS. Experience with treatment of opioid-abusing, pregnant women with buprenorphine indicates that it is safe for the fetus, and that NAS in these infants may be less severe than is seen in infants exposed to methadone in utero. Treatment of NAS with buprenorphine, relative to morphine, should be safe and may result in shorter hospital stays for treated infants. This is an R21 application to establish treatment parameters for NAS with sublingual buprenorphine, and to establish its safety (IND #68403).

描述（由申请人提供）：新生儿禁欲综合症（NAS）以55-94％的诊断或依赖阿片类药物依赖性母亲出生的婴儿（美国儿科毒品学会委员会，1998年），大约7000名处于危险的婴儿出生于美国每年（国家怀孕与健康调查，1996年）。据估计，有2.8％的孕妇使用非法药物，而在国际上考虑时，问题当然更大。经过其他健康治疗的婴儿的住院时间延长了，持续了几周到两个月，这是父母和婴儿的负担，并且财务影响很大。需要改善治疗选择。简单地说，从NAS的新生儿方面，目标将包括安全降低其发病率，严重性和持续时间，从而减少住院时间（以及与父母的同时分离）和接触其他药物。由于其部分MU阿片受体激动剂活性，高受体亲和力和较低的固有性阿片类药物活性，丁丙诺啡的药理学特征与美沙酮的药理学特征大不相同，美沙酮是母亲的治疗方法，与吗啡的治疗方法最广泛， NAS最广泛使用的药物治疗。治疗阿片类药物滥用的经验，丁丙诺啡的孕妇表明胎儿安全，并且这些婴儿中的NAS可能不如暴露于子宫内美沙酮的婴儿不那么严重。用丁丙诺啡相对于吗啡治疗NAS应该是安全的，并且可能导致治疗婴儿住院时间较短。这是R21的应用，以建立具有舌下丁丙诺啡的NAS的治疗参数，并确定其安全性（IND＃68403）。