IGF::OT::IGF CLINICAL TRIAL

这项双盲随机安慰剂对照试验评估了左乙拉西坦的有效性和安全性，从5个地点招募了130名酒精依赖患者，其中24%是女性，35%是少数民族。所有受试者都接受了左乙拉西坦或安慰剂，并接受了短暂的行为依从性增强治疗(BBCET)干预。根据临床部位和SSRI使用情况对患者进行分层。左乙拉西坦XR组和安慰剂组之间在主要结果(重度饮酒天数和非重度饮酒天数的百分比)或其他次级饮酒结果方面都没有显著差异。治疗组在一些不饮酒的结果上没有差异，包括抑郁、焦虑、情绪和生活质量。观察到的唯一区别是与酒精相关的后果。在维持期，左乙拉西坦XR治疗组的副作用明显少于安慰剂组(p=0.02)。左乙拉西坦XR耐受性良好，与安慰剂相比，疲劳是唯一显著增加的不良反应(分别为53%和24%；p=0.001)。研究结果发表在2012年《酒精中毒：临床和实验研究36：1421-1430,1421-1430》上。

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.