Cognitive Retraining and Brain Stimulation for Alcohol Use

The Mind Research Network

Status: Completed

Conditions: Binge Drinking

Treatments: Behavioral: Sham Retraining; Device: Sham TDCS; Behavioral: Active Retraining; Device: Active TDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02045108

1R21AA021201-01A1 (U.S. NIH Grant/Contract)

20-520

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 21 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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77 participants in 4 patient groups

Active TDCS + Active Retraining

Experimental group

Description:

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

Treatment:

Device: Active TDCS

Behavioral: Active Retraining

Sham TDCS + Active Retraining

Experimental group

Description:

.1 mA of TDCS applied during active alcohol avoidance retraining

Treatment:

Behavioral: Active Retraining

Device: Sham TDCS

Active TDCS + Sham retraining

Experimental group

Description:

2.0 mA of TDCS applied during sham alcohol avoidance retraining

Treatment:

Behavioral: Sham Retraining

Device: Active TDCS

Sham TDCS + Sham Retraining

Sham Comparator group

Description:

0.1 mA of TDCS applied during sham alcohol avoidance retraining

Treatment:

Behavioral: Sham Retraining

Device: Sham TDCS