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Cognitive Retraining and Brain Stimulation for Alcohol Use

Primary Purpose

Binge Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Retraining
Sham TDCS
Active TDCS
Sham Retraining
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Binge Drinking

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Active TDCS + Active Retraining

Sham TDCS + Active Retraining

Active TDCS + Sham retraining

Sham TDCS + Sham Retraining

Arm Description

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

.1 mA of TDCS applied during active alcohol avoidance retraining

2.0 mA of TDCS applied during sham alcohol avoidance retraining

0.1 mA of TDCS applied during sham alcohol avoidance retraining

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2014
Last Updated
March 16, 2018
Sponsor
The Mind Research Network
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02045108
Brief Title
Cognitive Retraining and Brain Stimulation for Alcohol Use
Official Title
Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Mind Research Network
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TDCS + Active Retraining
Arm Type
Experimental
Arm Description
2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining
Arm Title
Sham TDCS + Active Retraining
Arm Type
Experimental
Arm Description
.1 mA of TDCS applied during active alcohol avoidance retraining
Arm Title
Active TDCS + Sham retraining
Arm Type
Experimental
Arm Description
2.0 mA of TDCS applied during sham alcohol avoidance retraining
Arm Title
Sham TDCS + Sham Retraining
Arm Type
Sham Comparator
Arm Description
0.1 mA of TDCS applied during sham alcohol avoidance retraining
Intervention Type
Behavioral
Intervention Name(s)
Active Retraining
Intervention Type
Device
Intervention Name(s)
Sham TDCS
Intervention Type
Device
Intervention Name(s)
Active TDCS
Intervention Type
Behavioral
Intervention Name(s)
Sham Retraining
Primary Outcome Measure Information:
Title
Drinks Per Drinking Day
Description
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.
Time Frame
Screening Visit
Title
Alcohol Approach Bias
Description
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.
Time Frame
Baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
1 week post-baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
2 weeks post-baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
3 weeks post-baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
4 weeks post-baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
5 weeks post-baseline
Title
Drinks Per Drinking Day
Description
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.
Time Frame
8 weeks post-baseline
Title
Alcohol Approach Bias
Description
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.
Time Frame
1 week after treatment
Title
Drinks Per Drinking Day
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric D Claus, Ph.D.
Organizational Affiliation
Mind Research Network and LBERI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

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Cognitive Retraining and Brain Stimulation for Alcohol Use

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