Cognitive Retraining and Brain Stimulation for Alcohol Use

Not Applicable

Completed

• Conditions: Binge Drinking
• Interventions: Behavioral: Active Retraining; Device: Active TDCS; Behavioral: Sham Retraining; Device: Sham TDCS

• Registration Number: NCT02045108
• Lead Sponsor: The Mind Research Network

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 Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2018-01-29
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Results First Posted: 2018-03-20
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sham TDCS + Active Retraining	Active Retraining	.1 mA of TDCS applied during active alcohol avoidance retraining
Active TDCS + Active Retraining	Active Retraining	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining
Active TDCS + Sham retraining	Sham Retraining	2.0 mA of TDCS applied during sham alcohol avoidance retraining
Active TDCS + Sham retraining	Active TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining
Active TDCS + Active Retraining	Active TDCS	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining
Sham TDCS + Active Retraining	Sham TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining
Sham TDCS + Sham Retraining	Sham TDCS	0.1 mA of TDCS applied during sham alcohol avoidance retraining
Sham TDCS + Sham Retraining	Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining

Primary Outcome Measures

Name	Time	Method
Drinks Per Drinking Day	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	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.

Trial Locations

Locations (1)

The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction; 🇺🇸 Albuquerque, New Mexico, United States