The Effects of Zonisamide on Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase
研究概览
简要总结
In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zonisamide
In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study
干预措施: Zonisamide (Drug)
结局指标
主要结局
The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase
时间窗: Baseline and Week 12
The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.
Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).
时间窗: Week 0- Baseline and Week 12
Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.
次要结局
- Symbol Digit Modalities Test (DSMT)(Baseline, Week 12)