IGF::OT::IGF PROGRAM MANAGEMENT II

IGF::OT::IGF 项目管理 II

• 批准号: 9162787
• 负责人: JANET RANSOM
• 金额: $ 11.69万
• 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: 2015-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9162787
• 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; programs; 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，随机的安慰剂对照试验评估了5个地点，评估了Levetiracetam的疗效和安全性，招募了130名酒精依赖的患者，24％的妇女和35％的少数民族。所有受试者都接受了左甲乙酰氨酸或安慰剂，并进行了简短的行为依从性增强治疗（BBCET）干预措施。患者在临床部位进行分层，并使用SSRI。 在主要结局（大量饮酒的百分比和没有大量​​饮酒日的受试者百分比）或其他次要饮酒结果中，左甲乙酰氨酸XR和安慰剂组之间均未发现显着差异。治疗组在许多非抓斗结果上没有差异，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。在维持期间，左乙拉西坦XR治疗组的后果明显少于安慰剂组（p = 0.02）。 Levetiracetam XR耐受良好，与安慰剂相比，疲劳是唯一显着升高的不良事件（分别为53％和24％； P = 0.001）。该研究的结果发表在酒精中毒：临床和实验研究36：1421-1430，1421-1430，2012。