Cognitive Retraining and Brain Stimulation for Alcohol Use

NCT ID: NCT02045108

Last Updated: 2018-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Binge Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active TDCS + Active Retraining

2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining

Group Type EXPERIMENTAL

Active Retraining

Intervention Type BEHAVIORAL

Active TDCS

Intervention Type DEVICE

Sham TDCS + Active Retraining

.1 mA of TDCS applied during active alcohol avoidance retraining

Group Type EXPERIMENTAL

Active Retraining

Intervention Type BEHAVIORAL

Sham TDCS

Intervention Type DEVICE

Active TDCS + Sham retraining

2.0 mA of TDCS applied during sham alcohol avoidance retraining

Group Type EXPERIMENTAL

Active TDCS

Intervention Type DEVICE

Sham Retraining

Intervention Type BEHAVIORAL

Sham TDCS + Sham Retraining

0.1 mA of TDCS applied during sham alcohol avoidance retraining

Group Type SHAM_COMPARATOR

Sham TDCS

Intervention Type DEVICE

Sham Retraining

Intervention Type BEHAVIORAL

Interventions

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Active Retraining

Intervention Type BEHAVIORAL

Sham TDCS

Intervention Type DEVICE

Active TDCS

Intervention Type DEVICE

Sham Retraining

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

The Mind Research Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric D Claus, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mind Research Network and LBERI

Locations

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

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AA021201-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-520

Identifier Type: -

Identifier Source: org_study_id

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