IGF::OT::IGF CLINICAL TRIAL

IGF::OT::IGF 临床试验

• 批准号: 9162786
• 负责人: JANET RANSOM
• 金额: $ 648.49万
• 依托单位: FAST-TRACK DRUGS AND BIOLOGICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-09 至 2016-08-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9162786
• 关键词: Adverse event; Alcohol dependence; Alcoholism; Anxiety; Behavioral; Clinical Research; Double-Blind Method; Fatigue; Heavy Drinking; Intervention; Levetiracetam; Maintenance; Mental Depression; Moods; Outcome; Patients; Placebos; Publishing; Quality of life; Recruitment Activity; Safety; Selective Serotonin Reuptake Inhibitor; Site; Woman; alcohol related consequences; clinical research site; drinking; ethnic minority population; primary outcome; randomized placebo controlled trial; research study

This double-blind, randomized placebo-controlled trial evaluated the efficacy and safety of levetiracetam, recruiting 130 alcohol-dependent patients, 24% women and 35% ethnic minorities, from 5 sites. All subjects received either levetiracetam or placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET) intervention. Patients were stratified on clinical site, and SSRI use. No significant differences were detected between the levetiracetam XR and placebo groups in either the primary outcomes (percent heavy drinking days and percent subjects with no heavy drinking days) or in other secondary drinking outcomes. Treatment groups did not differ on a number of nondrinking outcomes, including depression, anxiety, mood, and quality of life. The only difference observed was in alcohol-related consequences. The levetiracetam XR treatment group showed significantly fewer consequences than did the placebo group during the maintenance period (p=0.02). Levetiracetam XR was well-tolerated, with fatigue being the only significantly elevated adverse event, compared with placebo (53% vs. 24%, respectively; p=0.001). Results of the study is published in Alcoholism: Clinical and Experimental Research 36:1421-1430, 1421-1430, 2012.

这项双盲、随机安慰剂对照试验评估了左乙拉西坦的疗效和安全性，从5个研究中心招募了130名酒精依赖患者，其中24%为女性，35%为少数民族。所有受试者均接受左乙拉西坦或安慰剂和短暂行为依从性增强治疗（BBCET）干预。根据临床试验机构和SSRI使用情况对患者进行分层。 左乙拉西坦XR组和安慰剂组在主要结局（重度饮酒天数百分比和无重度饮酒天数的受试者百分比）或其他次要饮酒结局方面均无显著差异。治疗组在一些非饮酒结果上没有差异，包括抑郁、焦虑、情绪和生活质量。观察到的唯一差异是与酒精相关的后果。在维持期内，左乙拉西坦XR治疗组的不良后果显著少于安慰剂组（p=0.02）。左乙拉西坦XR的耐受性良好，与安慰剂相比，疲劳是唯一显著升高的不良事件（分别为53%和24%; p=0.001）。研究结果发表在Alcoholism：Clinical and Experimental Research 36：1421-1430，1421-1430，2012。