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

LAAM 维护——围产期、短期和长期影响

• 批准号: 6270030
• 负责人: TOVE S. ROSEN
• 金额: $ 25.14万
• 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/6270030
• 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.

尽管美沙酮维持治疗与传统治疗相比具有一些明显的优势 怀孕海洛因成瘾者继续使用海洛因，例如更好的产前检查 护理，较大的婴儿，它的缺点是需要日常护理 诊所的管理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会出现 中度至重度戒断症状和表现的发生率很高 各种神经行为缺陷。 左旋-α-乙酰美沙多（LAAM）， 每周给予 3 次的长效阿片类药物可能会更好 维持治疗。 我们假设 LAAM 将产生更少的 严重的新生儿戒断综合症比美沙酮更方便患者 遵守。 目前还没有关于 LAAM 的信息 怀孕期间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 及其活性代谢物在不同时期的变化规律 怀孕、分娩时和新生儿分娩后。 自始至终 妊娠、药物使用调查问卷和尿液毒理学筛查 将会完成。 出生时，异常情况将由身体和身体状况决定 神经系统检查。 将进行布雷泽尔顿行为评估 评估反应能力。 戒断综合症的体征和症状 将在医院内和出院后 8 周内每天进行评估。 LAAM 消除率与发病率和严重程度相关 禁欲。 婴儿的后续评估将在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 每隔六个月施用一次。 此外，结构化 对产妇功能和产妇抑郁症状的评估将 被执行。 还将实施 HOME 评估量表。 将采用多变量分析来确定之间的关系 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组间比较 还将进行与美沙酮的比较。 这项研究将确定其功效、处置和影响 孕妇在怀孕期间服用 LAAM 与美沙酮的比较以及 后代的身体和神经发育。 使用此信息， 可以设计进一步的研究并可以制定干预计划 发达。