NCT00758277已完成3 期
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 11
- 主要终点
- Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
研究概览
简要总结
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
详细描述
Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse.
Secondary objective size are:
- Frequency of Lapses
- Time up to the first alcohol drinking
- cumulative times of do not drink
- Craving
- Alcohol drinking quantity
- Sleep quality
- Tolerability/Bearableness of the study medication
- Security
- Drop Out rate
- Side effects
- Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB, SCL-90.
- Quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 and not older than 70 years
- •Good knowledge of the German language
- •The criteria of an alcohol dependence after DSM IV and ICD 10 fulfill
- •To the recruiting time alkoholabstinently living, i.e. after successful alcohol decontamination, the patients must have understood the meaning and consequence of the study and have delivered before beginning of study your written agreement to the participation.
- •Negative drug screening regarding Benzodiazepines and Opiates.
- •With Females either o at least 1 year Menopause or after Sterilization or contraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormone plaster, hormone spiral at least 1 month before study inclusion or use of the double barrier method with Spermiziddiaphragma plus condom use or renouncement of sexual intercourse during the entire study duration and resolution a pregnancy to avoid with negative β-HCG-test
排除标准
- •Alcohol withdrawal syndrome beginning or existing
- •Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps
- •Specific ones behavior or deep-psychological single therapy or manual-led group therapies parallel to the clinical study
- •Any further substance dependence except nicotine and/or Caffeine dependence A abuse according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.
- •Idiopathic epilepsy, not however admitted alcohol withdrawal convulsions
- •Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. Polyneuropathie
- •current CO-medication by means of medicines, which can affect significantly withdrawal symptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics, antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparable effect mechanism) or Acamprosat, Disulfiram, or further substances, which can affect glutamaterge, dopaminerge, cholinergic, serotonerge or opiode system the GABAerge,
- •Contraindications or heavy side effects in relation to the study medication, hypersensitivity opposite Pyrrolidonderivate
- •Pregnancy or quiet time or insufficient Contraception
- •Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
- •Acute Suizidalität, not convincingly arrangementable
- •Severe internal illnesses, e.g. Pancreatitis, pneumonia, cardiac infarct, gastrointestinal bleedings etc.)
- •Severe kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers) and/or creatinin Clearance of small 30ml/min
- •Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).
研究组 & 干预措施
Levetiracetam
Active Comparator
干预措施: levetiracetam (Keppra) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
时间窗: During and after treatment
次要结局
- 1 Time up to first drinking(During treatment)
- 2 cumulative Time of do not drinking over the study duration(during treatment)
- Tolerability of the study medication(during treatment)
- Drop Out rate(during treatment)
- Side effects(during treatment)
- Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90(during treatment)
- Quality of life(during treatment)
- 3 Frequency of Lapses(during treatment)
研究者
研究点 (11)
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