Cognitive Retraining and Brain Stimulation for Alcohol Use

Overview

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.

Full Title of Study: “Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Interventions

  • Behavioral: Active Retraining
  • Device: Sham TDCS
  • Device: Active TDCS
  • Behavioral: Sham Retraining

Arms, Groups and Cohorts

  • Experimental: Active TDCS + Active Retraining
    • 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining
  • Experimental: Sham TDCS + Active Retraining
    • .1 mA of TDCS applied during active alcohol avoidance retraining
  • Experimental: Active TDCS + Sham retraining
    • 2.0 mA of TDCS applied during sham alcohol avoidance retraining
  • Sham Comparator: Sham TDCS + Sham Retraining
    • 0.1 mA of TDCS applied during sham alcohol avoidance retraining

Clinical Trial Outcome Measures

Primary Measures

  • Drinks Per Drinking Day
    • Time Frame: Screening Visit
    • 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
    • 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.
  • 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 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: 4 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: 5 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: 8 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.
  • Alcohol Approach Bias
    • Time Frame: 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.
  • 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 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Mind Research Network
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eric D Claus, Ph.D., Principal Investigator, Mind Research Network and LBERI

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