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临床试验/NCT02228486
NCT02228486Unknown不适用

Alcohol Cue-Reactivity in Patients With Alcohol Dependency and Effects of Transcranial Direct Current Stimulation (tDCS) on Cue-exposure Therapy

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
试验地点
2
主要终点
alcohol consumption days

研究概览

简要总结

Relapse is a major risk in substance abuse disorders, which is closely related to craving for a substance, describing a strong urge for consumption. Cue-exposure therapy is an intervention aiming at the reduction of perceived craving by repeated confrontation. It is based on the assumption that craving drops after repeated exposure without the reinforcing experience elicited by consumption. In the present study, patients with alcohol dependency take part in nine cue-exposure training sessions. Each session consists of mood induction reflecting a high risk situation with subsequent in vivo confrontation with one's preferred alcoholic beverage followed by the training of coping strategies. During the cue-exposure, patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that especially patients exhibiting initially high reactions to such cues should profit from this intervention the most. The reactions are measured on a subjective (craving) and physiological level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal activity). Furthermore, we want to strengthen the expected training effects during the cue-exposure by an activating transcranial direct current stimulation of the dorsolateral prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We investigate how the cue-exposure training affects the processing of alcoholic cues (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Clinical diagnosis of an alcohol dependence (F10.2)
  • abstinence motivation

排除标准

  • epileptic seizures
  • acute psychotic episode
  • another substance use disorder besides nicotine dependency (F17.2)
  • acute withdrawal symptoms

结局指标

主要结局

alcohol consumption days

时间窗: six months

次要结局

  • Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)(5 weeks)
  • subjective rating of self-efficacy (score on a 10 item-scale)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ann-Christine Ehlis

Dr.

University Hospital Tuebingen

研究点 (2)

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