Cognitive Retraining and Brain Stimulation for Alcohol Use

Study Overview
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Brief Summary
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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.

Official Title
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Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

Conditions
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Binge Drinking

Intervention / Treatment
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* Behavioral: Active Retraining
* Device: Sham TDCS
* Device: Active TDCS
* Behavioral: Sham Retraining


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TDCS + Active Retraining<br>2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining | Behavioral: Active Retraining<br> <br> Device: Active TDCS<br> <br> |
| Experimental: Sham TDCS + Active Retraining<br>.1 mA of TDCS applied during active alcohol avoidance retraining | Behavioral: Active Retraining<br> <br> Device: Sham TDCS<br> <br> |
| Experimental: Active TDCS + Sham retraining<br>2.0 mA of TDCS applied during sham alcohol avoidance retraining | Device: Active TDCS<br> <br> Behavioral: Sham Retraining<br> <br> |
| Sham Comparator: Sham TDCS + Sham Retraining<br>0.1 mA of TDCS applied during sham alcohol avoidance retraining | Device: Sham TDCS<br> <br> Behavioral: Sham Retraining<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinks Per Drinking Day | 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. | Screening Visit | 
| Alcohol Approach Bias | 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. | Baseline | 
| Drinks Per Drinking Day | 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. | 1 week post-baseline | 
| Drinks Per Drinking Day | 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. | 2 weeks post-baseline | 
| Drinks Per Drinking Day | 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. | 3 weeks post-baseline | 
| Drinks Per Drinking Day | 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. | 4 weeks post-baseline | 
| Drinks Per Drinking Day | 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. | 5 weeks post-baseline | 
| Drinks Per Drinking Day | 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. | 8 weeks post-baseline | 
| Alcohol Approach Bias | 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. | 1 week after treatment | 
| Drinks Per Drinking Day | 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. | Baseline |