Novel Glutamatergic Detoxification Strategies

新型谷氨酸解毒策略

• 批准号: 6952014
• 负责人: John H. Krystal
• 金额: $ 7.96万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-24 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6952014
• 关键词: NMDA receptors; alcoholism /alcohol abuse chemotherapy; alcoholism /alcohol abuse prevention; amantadine; anticonvulsants; anxiety; behavioral /social science research tag; clinical research; clinical trials; craving; depression; detoxification; drug /alcohol abstinence; drug adverse effect; drug screening /evaluation; drug withdrawal; emotional crisis; glutamate receptor; human subject; human therapy evaluation; neural transmission; statistics /biometry

DESCRIPTION (provided by applicant): This is a resubmission of an R21 proposal. This pilot study will compare the effectiveness of the lamotrigine and memantine to standard treatment of acute alcohol withdrawal and abstinence initiation in alcohol dependent patients, and the effect of these drugs on NDMA neurotransmission. A. Specific Aim 1: Are Memantine and Lamotrigine safe and effective detoxification strategies from alcohol in alcohol dependent individuals? 1. Do Lamotrigine and Memantine effectively treat the symptoms of alcohol withdrawal? 2. Do Lamotrigine and Memantine treat the emotional distress and depression associated with alcohol withdrawal in these patients? B. Specific Aim 2: Are Memantine and/or Lamotrigine effective in abstinence initiation and relapse prevention in the post-withdrawal (protracted withdrawal) phase in these individuals? 1. Are Memantine and/or Lamotrigine more effective than placebo in ameliorating depression, anxiety, and craving for alcohol in these patients? 2. Do Memantine and/or Lamotrigine prevent relapse to alcohol use more effectively than placebo in patients in the post-withdrawal (protracted withdrawal) phase ? Patients will be randomized to receive either memantine, lamotrigine, or a control strategy (Symptom Triggered Detoxification) (30 per group). All subjects will be recruited from the Leningrad Regional Center of Addictions affiliated with the St. Petersburg State PavIov Medical University (Russia). Only data analyses will be performed locally in New Haven. This pilot study will compare each active agent to placebo individually in order to evaluate these agents for a larger study. The primary outcomes are the number of patients successfully detoxified without additional benzodiazepine administered, Penn Alcohol Withdrawal Symptoms Checklist (PAWSC) and Clinical Institute Withdrawal Assessment Scale - Revised (CIWA-R) scores.

描述（由申请人提供）：这是R21提案的重新提交。 这项试点研究将比较lamotrigine和纪念碑的有效性与依赖酒精患者的急性酒精戒断和禁欲的标准治疗，以及这些药物对NDMA神经传递的影响。 答：特定目的1：在依赖酒精的个体中，纪念和拉莫三嗪安全有效的排毒策略是安全有效的吗？ 1。拉莫三嗪和美金刚素能有效地治疗戒酒的症状吗？ 2. lamotrigine和美金刚治疗这些患者的情绪困扰和抑郁症？ B.具体目的2：这些个体的纪念阶段（持久戒断）阶段中有效的戒酒和/或拉莫三嗪可有效预防。 1。在这些患者的抑郁，焦虑和渴望酒精的抑郁症中，美金刚和/或拉莫三嗪比安慰剂更有效吗？ 2。在withdrawal（持久戒断）阶段中，美金刚和/或拉莫三嗪是否比安慰剂更有效地防止饮酒复发？ 患者将随机接受美金刚，拉莫三嗪或对照策略（症状触发排毒）（每组30）。所有科目将从列宁格勒地区成瘾中心招募，隶属于圣彼得堡州立大学帕维奥夫医科大学（俄罗斯）。只有数据分析将在纽黑文本地进行。这项试验研究将将每个活性剂与安慰剂分别进行比较，以评估这些药物以进行更大的研究。主要结果是成功排毒的患者人数，没有额外的苯二氮卓，宾夕法尼亚州酒精戒断症状清单（PAWSC）和临床研究所的戒断评估量表 - 修订后（CIWA -R）得分。