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临床试验/NCT00874003
NCT00874003已完成2 期

The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Alcohol consumption measured by alcohol diary (units/week).

研究概览

简要总结

The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 18-65 years of age
  • alcohol high consumption
  • signed informed consent

排除标准

  • psychiatric disorders (except nicotine and alcohol dependence)
  • severe somatic disorders
  • inadequate knowledge of the Swedish language

研究组 & 干预措施

mirtazapine, tablet, 30 mg

Experimental

n=29

干预措施: mirtazapine (Drug)

sugar pill

Placebo Comparator

n=30

干预措施: placebo (Drug)

结局指标

主要结局

Alcohol consumption measured by alcohol diary (units/week).

次要结局

未报告次要终点

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other

研究点 (1)

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