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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)的确诊病例为55-94%或由阿片类药物依赖母亲所生的婴儿(美国儿科学会药物委员会，1998年)，美国每年约有7000名高危婴儿出生(全国怀孕与健康调查，1996年)。据估计，2.8%的孕妇使用非法药物，从国际上来看，这个问题当然更大。接受其他健康治疗的婴儿的住院时间延长，从几周到两个月不等，这对父母和婴儿都是负担，并对经济产生巨大影响。有必要改进治疗方案。简单地说，从NAS的新生儿方面来看，目标将包括安全地降低其发病率、严重性和持续时间，从而减少住院时间(以及同时与父母分离)和接触其他药物。由于丁丙诺啡具有部分MU阿片受体激动剂活性，受体亲和力高，内源性阿片活性低，其药理特征与母亲最广泛使用的美沙酮和治疗NAS最广泛使用的药物之一吗啡的药理特征有很大不同。使用丁丙诺啡治疗阿片类药物滥用的经验表明，丁丙诺啡对胎儿是安全的，这些婴儿的NAS可能没有在宫内接触美沙酮的婴儿严重。相对于吗啡，丁丙诺啡治疗NAS应该是安全的，并可能导致接受治疗的婴儿住院时间缩短。这是一个R21应用程序，用于建立舌下含丁丙诺啡的非酒精性鼻炎的治疗参数，并建立其安全性(IND#68403)。