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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 Tuebingen1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
48
试验地点
1
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
否

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

研究组 & 干预措施

Cue Exposure Therapy and verum tDCS

Active Comparator

During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).

干预措施: tDCS (Device)

Cue Exposure Therapy and verum tDCS

Active Comparator

During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).

干预措施: Cue Exposure Therapy (Behavioral)

Cue Exposure Therapy and sham tDCS

Placebo Comparator

During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.

干预措施: Cue Exposure Therapy (Behavioral)

Waiting list control group

No Intervention

The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study

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 (1)

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