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临床试验/NCT03028662
NCT03028662已完成不适用

New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Gabriel Rubio Valladolid, MD2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2016年1月1日最近更新:
适应症

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

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

发起方
Gabriel Rubio Valladolid, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gabriel Rubio Valladolid, MD

Psychiatrist, MD, PhD

Hospital Universitario 12 de Octubre

研究点 (2)

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