Results from a randomized controlled trial of zonisamide in the treatment of alcohol use disorder

IF 3.7 2区 医学 Q1 PSYCHIATRY
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Abstract

There is preliminary evidence that the anticonvulsant medication Zonisamide (ZON) may be an effective, well-tolerated treatment for alcohol use disorder (AUD). However, further evaluation of its efficacy for treating patients with AUD is needed, and much remains unknown about ZON's therapeutic mechanisms. The present study aimed to evaluate the efficacy and tolerability of ZON in a double-blind, placebo-controlled, randomized trial. Eighty-one adults (ages 21–65) diagnosed with AUD were randomly assigned to receive either ZON (at a target dose of 400 mg/d) or a pill placebo over 12 weeks, followed by a two-week taper. All participants also received a computerized alcohol reduction program, Take Control (TC). Primary drinking outcomes were average daily drinks, percentage drinking days, and percentage heavy drinking days. Further, we evaluated changes in AUD clinical severity and performance on neuropsychological measures. For both groups, drinking outcomes generally decreased, as did AUD clinical severity, though group differences were not statistically significant. Neuropsychological testing performance was similar for both groups at baseline; however, at post-treatment, participants in the ZON group demonstrated poorer working memory and lower performance on verbal fluency tests compared to the placebo group, and these differences were statistically significant with moderate-large effect sizes. One serious adverse event was reported among individuals receiving ZON. Study findings indicate that ZON combined with TC does not demonstrate superior effectiveness for reducing average daily drinks in this clinical sample with principal AUD compared to placebo and TC, and treatment with ZON may be associated with reduced neurocognitive performance over time.

唑尼沙胺治疗酒精使用障碍的随机对照试验结果
有初步证据表明,抗惊厥药物唑尼沙胺(ZON)可能是一种有效且耐受性良好的酒精使用障碍(AUD)治疗药物。然而,还需要进一步评估其对治疗 AUD 患者的疗效,而且 ZON 的治疗机制仍有许多未知之处。本研究旨在通过一项双盲、安慰剂对照、随机试验评估 ZON 的疗效和耐受性。81名确诊为 AUD 的成年人(21-65 岁)被随机分配到 ZON(目标剂量为 400 毫克/天)或药片安慰剂组,接受为期 12 周的治疗,然后再进行为期两周的减量治疗。所有参与者还接受了计算机化的减酒计划--Take Control (TC)。主要饮酒结果为日平均饮酒量、饮酒天数百分比和大量饮酒天数百分比。此外,我们还评估了 AUD 临床严重程度和神经心理测量表现的变化。两组的饮酒结果和 AUD 临床严重程度都普遍下降,但组间差异无统计学意义。基线时,两组的神经心理学测试表现相似;但在治疗后,与安慰剂组相比,ZON组参与者的工作记忆能力较差,语言流畅性测试成绩较低,这些差异具有统计学意义,效应大小中等偏大。接受ZON治疗的患者中报告了一起严重不良事件。研究结果表明,与安慰剂和TC相比,ZON联合TC在减少主要AUD临床样本的日均饮酒量方面并没有显示出更好的疗效,而且随着时间的推移,ZON治疗可能会导致神经认知能力下降。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of psychiatric research
Journal of psychiatric research 医学-精神病学
CiteScore
7.30
自引率
2.10%
发文量
622
审稿时长
130 days
期刊介绍: Founded in 1961 to report on the latest work in psychiatry and cognate disciplines, the Journal of Psychiatric Research is dedicated to innovative and timely studies of four important areas of research: (1) clinical studies of all disciplines relating to psychiatric illness, as well as normal human behaviour, including biochemical, physiological, genetic, environmental, social, psychological and epidemiological factors; (2) basic studies pertaining to psychiatry in such fields as neuropsychopharmacology, neuroendocrinology, electrophysiology, genetics, experimental psychology and epidemiology; (3) the growing application of clinical laboratory techniques in psychiatry, including imagery and spectroscopy of the brain, molecular biology and computer sciences;
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