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随机试验评估美金刚在酒精使用障碍住院治疗期间给药的安全性/可行性:一项试点研究。

Randomized trial to assess safety/feasibility of memantine administration during residential treatment for alcohol use disorder: a pilot study.

机构信息

Department of Psychiatry, University of Florida, Gainesville, FL, USA.

Center for Addiction Research & Education, University of Florida, Gainesville, FL, USA.

出版信息

J Addict Dis. 2020 Apr-Jun;38(2):91-99. doi: 10.1080/10550887.2020.1721404. Epub 2020 Feb 12.

Abstract

The -methyl--aspartate receptor (NMDAr) system is critically involved in the pathogenesis and neurobehavioral sequelae of alcohol use disorder (AUD), and constitutes a potential pharmacotherapeutic target. Memantine (Namenda) is an FDA-approved NMDAr antagonist with suggested utility in AUD, however its safety and tolerability during long-term administration among recently-detoxified patients remains uncharacterized. This pilot study assessed safety, feasibility, and several secondary measures of interest, during a 4-week period of residential AUD treatment. Participants ( = 18) met diagnostic criteria for AUD. A double-blind, placebo-controlled, escalating-dose design was utilized. Assessments of medication side-effects were conducted weekly. At intake, week 2, and study completion, participants completed a battery assessing affective symptomatology, craving, and neurocognitive function. Medication groups reported equivalent side effects and severity. Medication compliance was high, and did not differ by group. No memantine effects were observed in secondary outcome measures. Memantine maintains a profile of high tolerability and low side-effects during post-detoxification AUD treatment. These data suggest a more aggressive dosing/escalation schedule may be used safely in future trials designed to ascertain improvements in neurocognitive function, affect, and/or craving as primary measures.

摘要
  • 甲基-D-天冬氨酸受体(NMDAr)系统在酒精使用障碍(AUD)的发病机制和神经行为后果中起着至关重要的作用,是一个潜在的药物治疗靶点。美金刚(Namenda)是一种获得 FDA 批准的 NMDAr 拮抗剂,在 AUD 中具有潜在用途,然而,在最近戒毒的患者中长期使用时的安全性和耐受性仍不清楚。这项初步研究评估了在住院 AUD 治疗期间的 4 周内的安全性、可行性和几个次要的感兴趣指标。参与者( = 18)符合 AUD 的诊断标准。采用双盲、安慰剂对照、递增剂量设计。每周评估一次药物副作用。在摄入时、第 2 周和研究完成时,参与者完成了一套评估情感症状、渴望和神经认知功能的测试。药物组报告了等效的副作用和严重程度。药物依从性高,且组间无差异。在次要结局指标中未观察到美金刚的作用。美金刚在戒毒后 AUD 治疗期间保持高耐受性和低副作用的特征。这些数据表明,在未来旨在确定神经认知功能、情绪和/或渴望等主要指标改善的试验中,可以更积极地使用递增剂量/递增方案。

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