EUCTR2007-004134-16-DE进行中（未招募）不适用
Effectiveness and Safety of Pregabalin (Lyrica) in treatment of in-patients with ethanol withdrawal syndrom - PRAW
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-age between 18 and 65
- •- knowledge of german language
- •- alcohol dependence in DSM IV and ICD-10
- •- alcohol withdrawal syndrome in DSM IV and ICD-10 with AWSS-sum >=4
- •- negative drog screening for heroin, cocaine, benzodiazepine, methadone
- •- written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- beginning or present delirium tremens, but not delirium tremens in history
- •- an additional dependence, except nicotine/caffeine
- •- present seizure disorders, except alcohol withdrawal convulsions
- •- history of brain injuries or other neurological diseases, except alcohol related neurological disorders, e.g. polyneuropathy
- •- present continious medication with drugs that influence withdrawal symptoms (benzodiazepines, neuroleptics,anti-epileptic drugs, antihypertensive drugs)
- •- contraindications or severe events for one of the following drugs: diazepam, pregabalin, clonidin, haloperidol
- •- pregnancy, lactation,insufficient contraception
- •- other psychiatric axis 1 diseases, except alcohol dependancy
- •- acute suicidal tendency
- •- severe internal diseases like pancreatitis, pneumonia, coronar heart disease, hypertension, gastro-intestinal bleeding
- •- severe hepatic damage, severe renal lesion
- •- participation in an other clinical trial during, either contemporaneous or during the last 4 weeks
- •- compulsory admission
研究者
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