Cognitive Retraining and Brain Stimulation for Alcohol Use

Binge Drinking Clinical Trial

Official title:

Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045108
• Other study ID #: 20-520
• Secondary ID: 1R21AA021201-01A
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: March 16, 2018
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: The Mind Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Drinking

Intervention

Behavioral:
• Active Retraining

Device:
• Sham TDCS

• Active TDCS

Behavioral:
• Sham Retraining

Locations

Country	Name	City	State
United States	The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
The Mind Research Network	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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