Cognitive Retraining and Brain Stimulation for Alcohol Use

Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

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.

Study Overview

• Status: Completed
• Conditions: Binge Drinking
• Intervention / Treatment: Behavioral: Active Retraining; Device: Active TDCS; Device: Sham TDCS; Behavioral: Sham Retraining

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Mind Research Network
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Eric D Claus, Ph.D., Mind Research Network and LBERI

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Binge Drinking
• Other Study ID Numbers: 20-520; 1R21AA021201-01A1 (U.S. NIH Grant/Contract)