EUCTR2011-003133-34-SE进行中(未招募)1 期
The Effects of the Dopamine Stabilizer (-)-OSU6162 on Craving and Impulsivity in Alcohol Dependent Patients
A. Carlsson Research AB0 个研究点目标入组 56 人开始时间: 2011年10月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 56
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
- •Male or a non-pregnant/non-nursing female between 20 and 55 years of age
- •Minimum of nine years of education
- •Fulfils at least 4 out of 7 criteria for alcohol dependence according to DSM-IV, at least one of the criteria for loss of control of drinking or an inability to cut down or quit needs to be fulfilled
- •30 heavy drinking days (at least 5 or 4 standard drinks per day for men and women respectively) within the last 60 days before screening
- •Minimum 7 and maximum 14 alcohol-free days before day of inclusion
- •Be willing to give informed consent and comply with study procedures
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Have a current use of any psychoactive medication
- •Fulfils DSM IV diagnosis of any other substance dependence disorder (except nicotine)
- •Fulfils DSM IV diagnosis of any major psychological or psychiatric illness e.g. schizophrenia, bipolar disorder and major depression
- •Previous withdrawal-induced delirium tremens or seizures
- •Presence of any serious somatic or neurological disorder e.g. significant electrolytic imbalance, liver cirrhosis, kidney failure, dementia or Wernicke-Korsakow
- •Presence of any previous heart disease or clinically relevant ECG abnormality e.g. arrhythmias, bundle branch block or QT interval or T wave alterations (all subjects with intermediate or high risk for Long QT syndrome will be excluded)
- •Impaired sense of smell
- •Use of any illegal drugs for the last 30 days
- •Traces of alcohol as measured by breathalyzer on the day of the testing (Day 14) and the three rescheduled test occasions
- •Traces of any other psychoactive substance (e.g. central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample on inclusion day or during the course of the study
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