Clinical trial NCT02045108: Cognitive Retraining and Brain Stimulation for Alcohol Use
Official title: Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Drinking
Lead sponsor: The Mind Research Network
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-01-24
Enrollment: 77
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Drinks Per Drinking Day
timeFrame: Screening Visit
measure: Alcohol Approach Bias
timeFrame: Baseline
measure: Drinks Per Drinking Day
timeFrame: 1 week post-baseline
measure: Drinks Per Drinking Day
timeFrame: 2 weeks post-baseline
measure: Drinks Per Drinking Day
timeFrame: 3 weeks post-baseline
measure: Drinks Per Drinking Day
timeFrame: 4 weeks post-baseline
measure: Drinks Per Drinking Day
timeFrame: 5 weeks post-baseline
measure: Drinks Per Drinking Day
timeFrame: 8 weeks post-baseline
measure: Alcohol Approach Bias
timeFrame: 1 week after treatment
measure: Drinks Per Drinking Day
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction
state: New Mexico
Study officials:
affiliation: Mind Research Network and LBERI
name: Eric D Claus, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: