EFFICACY OF LAAM MAINTENANCE FOR OPIOID DEPENDENT PREGNANT WOMEN

LAAM 维持治疗对阿片类药物依赖孕妇的功效

• 批准号: 6304937
• 负责人: SIDNEY H. SCHNOLL
• 金额: $ 0.06万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304937
• 关键词: clinical research; drug abuse chemotherapy; drug screening /evaluation; endogenous opioid; female; human pregnant subject; human subject; human therapy evaluation

An attempt to determine the effectiveness of LAAM (levo-alpha acetyl methadol) for opiod dependent pregnant women. Traditionally, methadone has been used to treat opioid addiction in both pregnant and non-pregnant patients. LAAM is a recently approved opioid agonist chemically similar to methadone, which offers the advantage of every-other-day dosing. However, studies regarding the use of LAAM in pregnant patients are virtually nonexistant, so the safety, efficiency, and optimal dosing of this new agent in pregnant patients is not known. The goal of this study is to realize the efficiency, the way the body reacts, and the best dosing that will prevent withdrawal symptoms in both the mother and the newborn, but does not produce opioid intoxication in the mother or adverse effects in the fetus. Subjects will be pregnant opioid-dependent women who pass inclusion criteria. Physical and psychological exams will be given, urine and blood will be tested. Tests for various diseases will be done and patients will be informed of their results. There will be a 2-3 week stay at the research clinic where the patients will be monitored. Then methadone will be given until the patient reaches the adequate maintenance dose. Then, after stability on methadone, patients will be placed and maintained on an adequate dose of LAAM. While at the clinic, patients will complete questionnaires. When visit is complete, patients will return on an out-patient basis and receive their LAAM dosage. This will continue until the birth of the babies and for six months after that. At the completion of the study, patients will be transferred to methadone and referred to a methadone clinic.

试图确定LAAM（左- α乙酰美沙多）对阿片类药物依赖孕妇的有效性。传统上，美沙酮用于治疗怀孕和非怀孕患者的阿片类药物成瘾。LAAM是一种最近被批准的阿片类激动剂，化学性质与美沙酮相似，具有隔天给药的优点。然而，关于妊娠患者使用LAAM的研究几乎不存在，因此这种新药在妊娠患者中的安全性、有效性和最佳剂量尚不清楚。本研究的目的是实现效率、身体反应方式和最佳剂量，以防止母亲和新生儿出现戒断症状，但不会对母亲产生阿片类药物中毒或对胎儿产生不良影响。受试者为符合纳入标准的阿片类药物依赖孕妇。体检和心理检查，尿检和血检。将对各种疾病进行检查，并将检查结果告知患者。将在研究诊所停留2-3周，对患者进行监测。然后给予美沙酮，直到患者达到足够的维持剂量。然后，在美沙酮稳定后，患者将被放置并维持足够剂量的LAAM。在诊所，病人将完成问卷调查。当访问完成后，患者将以门诊为基础返回并接受他们的LAAM剂量。这将持续到婴儿出生，并在那之后的六个月。在研究结束时，患者将被转移到美沙酮治疗，并转介到美沙酮诊所。