Clinical Trial: Cognitive Retraining and Brain Stimulation for Alcohol Use

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

Brief Summary: 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.

Detailed Summary:
Sponsor: The Mind Research Network

Current Primary Outcome:

  • Drinks per drinking day [ Time Frame: Baseline ]
    Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day of the prior 30 days. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.
  • Alcohol approach bias [ Time Frame: Baseline ]
    Response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick
  • Drinks per Drinking Day [ Time Frame: 1 week post-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.
  • Drinks per Drinking Day [ Time Frame: 2 weeks post-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.
  • Drinks per Drinking Day [ Time Frame: 3 weeks post-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 th

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • BOLD response during approach and avoid responses to alcohol [ Time Frame: Baseline ]
      Blood oxygen level dependent responses will be examined prior to and post-treatment to determine if these responses change differentially by treatment group. The BOLD response is a proxy measure of blood flow in the brain that occurs in response to the presentation of a sensory stimulus, in this case pictures of alcohol-contain beverages. We will examine the change in BOLD response from before treatment to after treatment in a subset (~1/2 of the total sample, distributed across all 4 treatment arms) of the participants who complete the MRI assessments.
    • BOLD response during approach and avoid responses to alcohol [ Time Frame: 1 week post-treatment ]
      Blood oxygen level dependent responses will be examined prior to and post-treatment to determine if these responses change differentially by treatment group. The BOLD response is a proxy measure of blood flow in the brain that occurs in response to the presentation of a sensory stimulus, in this case pictures of alcohol-contain beverages. We will examine the change in BOLD response from before treatment to after treatment in a subset (~1/2 of the total sample, distributed across all 4 treatment arms) of the participants who complete the MRI assessments.


    Original Secondary Outcome: Same as current

    Information By: The Mind Research Network

    Dates:
    Date Received: January 20, 2014
    Date Started: January 2014
    Date Completion:
    Last Updated: March 14, 2016
    Last Verified: March 2016