NCT00926900Unknown2 期
The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Central Institute of Mental Health, Mannheim1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
研究概览
简要总结
The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function.
It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity.
Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •current DSM-IV/ ICD-10 diagnosis of alcohol dependence
- •controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care
- •women (in childbearing age): use of a highly effective method of contraception
- •normal or corrected-to-normal vision
- •ability to provide written informed consent
排除标准
- •diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence)
- •positive drug screening
- •current medication with anti-convulsive or psychotropic drugs
- •MRI ineligibility
- •sensitivity to study medication as evidenced by a history of adverse drug experience
- •severe withdrawal symptoms (e.g. convulsions, delirium)
- •disposition towards experiencing convulsions/ epilepsy
- •history of schizophrenic disorders/ affective psychosis
- •neurological diseases that might affect the dopaminergic, limbic and frontal cortices or extrapyramidal motor functioning
- •major diseases (e.g. diabetes, liver cirrhosis, heart disease)
- •physical illness interfering with study procedures or affecting study outcomes
- •pregnancy (positive test results)/ lactation period
- •suicidal tendencies/ increased risk that others might be harmed -
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
D-cycloserine
Active Comparator
干预措施: D-cycloserine (Drug)
结局指标
主要结局
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
时间窗: following completion of cue-exposure therapy
次要结局
- time to first severe relapse to alcohol consumption(at 3 and 6 months after treatment completion)
研究者
研究点 (1)
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