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Completed

NCT Number: NCT02045108

Cognitive Retraining and Brain Stimulation for Alcohol Use

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.

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Key information

Conditions

Binge Drinking Alcohol Drinking Alcohol-Related Disorders Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction

Albuquerque, New Mexico, 87106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Retraining

Behavioral

Sham tDCS

Device

active tDCS

Device

Sham Retraining

Behavioral

Primary outcomes

  1. Drinks Per Drinking Day

    Time frame: Screening Visit

    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.

  2. Alcohol Approach Bias

    Time frame: Baseline

    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.

  3. Drinks Per Drinking Day

    Time frame: 1 week post-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.

  4. Drinks Per Drinking Day

    Time frame: 2 weeks post-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.

  5. Drinks Per Drinking Day

    Time frame: 3 weeks post-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.

  6. Drinks Per Drinking Day

    Time frame: 4 weeks post-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.

  7. Drinks Per Drinking Day

    Time frame: 5 weeks post-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.

  8. Drinks Per Drinking Day

    Time frame: 8 weeks post-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.

  9. Alcohol Approach Bias

    Time frame: 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.

  10. Drinks Per Drinking Day

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Mind Research Network

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2014
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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