LAAM MAINTENANCE--PERINATAL, SHORT, AND LONG TERM EFFECTS

LAAM 维护——围产期、短期和长期影响

• 批准号: 6104083
• 负责人: TOVE S. ROSEN
• 金额: $ 3.9万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 1999-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6104083
• 关键词: behavior test; clearance rate; developmental neurobiology; drug abuse chemotherapy; drug withdrawal; embryo /fetus drug adverse effect; embryo /fetus pharmacology; embryo /fetus toxicology; heroin; human pregnant subject; human therapy evaluation; longitudinal human study; methadone; methadylacetate; neuropsychological tests; newborn human (0-6 weeks); pregnancy; prenatal care; preschool child (1-5); questionnaires; statistics /biometry; therapy compliance; urinalysis; women's health

Although methadone maintenance has some distinct advantages compared to continued heroin use for pregnant heroin addicts, e.g., better prenatal care, bigger infants, it has the disadvantages of needing daily administration of a clinic to avoid withdrawal symptoms and diversion of take-home doses. Further, infants exposed to methadone in utero have a high incidence of moderate to severe abstinence symptoms and display various neurobehavioral deficiencies. Levo-alpha-acetylmethadol (LAAM), a long-acting opiate which is given three times a week, may be a better maintenance treatment. We hypothesize that LAAM will produce a less severe neonatal abstinence syndrome than methadone and facilitate patient compliance. At present there is no information regarding LAAM's disposition in pregnancy or its possible effects on the neonate. This project will determine the half life of elimination and excretion patterns of LAAM and its active metabolites during various periods of the pregnancy, at delivery, and after delivery in the neonate. Throughout the pregnancy, drug use questionnaires and urine toxicology screening will be done. At birth, abnormalities will be determined by physical and neurological exam. A Brazelton Behavioral Assessment will be performed to assess responsiveness. Signs and symptoms of an abstinence syndrome will be evaluated daily in the hospital and after discharge for 8 weeks. Rates of LAAM elimination will be correlated to incidence and severity of abstinence. Follow-up evaluations of the infants will be done repeatedly at 6, 9, 12, 15, 21 and 24 months. To determine neurobehavioral development, a neurological exam and the Bayley Scales of Mental Motor Development will be administered at six month intervals. Additionally, structured assessments of maternal functioning and maternal depressive symptoms will be performed. HOME assessment scale will also be administered. Multivariate analysis will be employed to determine relationships between LAAM and other drugs abused, perinatal and maternal psychosocial variables and neurodevelopmental outcome. Group comparisons of LAAM versus methadone will also be made. This study will determine the efficacy, disposition, and effects of pregnant women on LAAM versus methadone during pregnancy as well as the physical and neurodevelopment of the offspring. Using this information, further studies can be designed and intervention programs may be developed.

虽然美沙酮维持疗法与传统的美沙酮疗法相比有一些明显的优势， 怀孕的海洛因成瘾者继续使用海洛因，例如，更好的产前 护理，较大的婴儿，它的缺点是需要每天 管理诊所，以避免戒断症状和转移 带回家的剂量 此外，在子宫内接触美沙酮的婴儿 中度至重度戒断症状发生率高， 各种神经行为缺陷 左旋-α-乙酰美沙醇（LAAM）， 一周服用三次的长效阿片类药物可能是一种更好的方法。 维持治疗。 我们假设LAAM会产生更少的 重度新生儿戒断综合征较美沙酮更有利于患者 合规 目前没有关于LAAM的信息 妊娠中的倾向或其对新生儿的可能影响。 这 项目将确定消除和排泄的半衰期 LAAM及其活性代谢产物在不同时期的模式 妊娠、分娩时和新生儿分娩后。 在整个 妊娠、药物使用问卷和尿液毒理学筛查 会完成的 出生时，将通过体格检查和 神经系统检查。将进行Brazelton行为评估 来评估响应能力。 戒断综合征的症状和体征 将在医院和出院后每天进行评估，持续8周。 LAAM消除率将与发生率和严重程度相关 禁欲 对婴儿的随访评估将在6、9、12、 15、21和24个月。 为了确定神经行为发育， 神经系统检查和贝利心理运动发展量表将 每隔六个月给药一次。 此外，结构化 对母亲功能和母亲抑郁症状的评估将 被执行。 还将进行HOME评估量表。 将采用多变量分析来确定 LAAM和其他药物滥用、围产期和孕产妇心理社会 变量和神经发育结果。 LAAM的组比较 与美沙酮的对比。 本研究将确定以下药物的疗效、处置和影响： 妊娠期间服用LAAM与美沙酮的孕妇以及 后代的身体和神经发育。 利用这些信息， 可以设计进一步的研究和干预方案， 开发