New Therapeutic Strategies for the Treatment of Alcohol Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Number of relapses during 3 months after training-extinction
研究概览
简要总结
This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.
详细描述
Behavioral inhibition processes are a particularly relevant in relapses of patients with alcohol dependence. One of the current behavioral techniques to improve inhibitory abilities of these patients is the alcohol Approach Avoidance Task (AAT). However, this technique could be more efficient if patients, before training in this task, were exposed to a variety of alcohol-conditioned stimuli (retrieval) and take advantage of the window period of reconsolidation of these memories to carry out this task (extinction training). This project will attempt to show the pattern of brain connectivity underlying retrieval-extinction learning, its relationship with markers such as Brain-Derived Neurotrophic Factor (BDNF) and their usefulness to reduce relapses of individual with alcohol dependence. To carry out this study 115 patients with alcohol dependence who will be randomized into three groups: Group 1 (N = 35) where the extinction training is performed within the window period (10 minutes); Group 2 (N = 35) extinction will take place outside the time window (6 hours); Group 3 (N = 35), these subjects will be exposed to "non-retrieval" but with extinction-training within the window period. Changes in connectivity will be assessed with Electroencephalogram (EEG) at baseline and after 4 training sessions, using the HERMES platform. BDNF levels will be determined as peripheral markers of neurogenesis. These changes will be are correlated with relapses in the 12 weeks of follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol-dependent patients who have been detoxified and abstinent take 10-14 days.
排除标准
- •Patients who do not sign the informed consent.
结局指标
主要结局
Number of relapses during 3 months after training-extinction
时间窗: 3 months
Difference between pattern of brain connectivity after training-extinction and basal level
时间窗: 2 days
次要结局
- Difference between attentional bias toward alcohol after training-extinction and basal level(2 days)
- Difference between plasma levels of BDNF after training-extinction and basal level(2 days)
- Difference between behavioral inhibition after training-extinction and basal level(2 days)
研究者
Gabriel Rubio Valladolid, MD
Psychiatrist, MD, PhD
Hospital Universitario 12 de Octubre
