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临床试验/NCT02045108
NCT02045108已完成不适用

Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

The Mind Research Network2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
Drinks Per Drinking Day

研究概览

简要总结

The overarching goal of this study is to determine whether combined cognitive training and Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To this end, specific study purposes are: 1) replicate previous findings that cognitive retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS. We hypothesize that those participants who receive alcohol avoidance cognitive training will have greater reductions in drinking. In turn, those participants who receive a higher level of applied tDCS during alcohol avoidance response training will have better avoidance learning, as well as, a larger reduction in drinking behavior. Finally, those participants receiving a higher level of applied tDCS will have more neuronal response associated with alcohol avoidance during the brain imaging session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21-30 years
  • At least five binge drinking episodes (4+ drinks for men; 3+ drinks for women) for the past month
  • Alcohol Use Disorder Identification Test (AUDIT) score greater than 8
  • Right handed

排除标准

  • History of treatment for alcohol dependence (AD) or desire for treatment
  • History of alcohol withdrawal
  • History of brain injury
  • Currently taking psychotropic medications (e.g. antidepressants, antipsychotics)
  • Female subjects who are pregnant
  • Evidence of recent illicit drug use on a urine screen
  • Left handed
  • Prior participation in a brain stimulation study
  • Implanted brain medical devices
  • Electromedical devices
  • Latex allergy

研究组 & 干预措施

Sham TDCS + Sham Retraining

Sham Comparator

0.1 mA of TDCS applied during sham alcohol avoidance retraining

干预措施: Sham TDCS (Device)

Sham TDCS + Sham Retraining

Sham Comparator

0.1 mA of TDCS applied during sham alcohol avoidance retraining

干预措施: Sham Retraining (Behavioral)

Sham TDCS + Active Retraining

Experimental

.1 mA of TDCS applied during active alcohol avoidance retraining

干预措施: Active Retraining (Behavioral)

Sham TDCS + Active Retraining

Experimental

.1 mA of TDCS applied during active alcohol avoidance retraining

干预措施: Sham TDCS (Device)

Active TDCS + Sham retraining

Experimental

2.0 mA of TDCS applied during sham alcohol avoidance retraining

干预措施: Active TDCS (Device)

Active TDCS + Sham retraining

Experimental

2.0 mA of TDCS applied during sham alcohol avoidance retraining

干预措施: Sham Retraining (Behavioral)

Active TDCS + Active Retraining

Experimental

2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining

干预措施: Active Retraining (Behavioral)

Active TDCS + Active Retraining

Experimental

2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining

干预措施: Active TDCS (Device)

结局指标

主要结局

Drinks Per Drinking Day

时间窗: Baseline

Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.

Alcohol Approach Bias

时间窗: 1 week after treatment

For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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