Cognitive Retraining and Brain Stimulation for Alcohol Use

• Sponsor: The Mind Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT02045108
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 77
• Location: 1
• Arms: 4
• Duration (Months): 23
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Drinking	Behavioral: Active Retraining; Device: Sham TDCS; Device: Active TDCS; Behavioral: Sham Retraining	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active TDCS + Active Retraining 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining	Behavioral: Active Retraining; Device: Active TDCS
Experimental: Sham TDCS + Active Retraining .1 mA of TDCS applied during active alcohol avoidance retraining	Behavioral: Active Retraining; Device: Sham TDCS
Experimental: Active TDCS + Sham retraining 2.0 mA of TDCS applied during sham alcohol avoidance retraining	Device: Active TDCS; Behavioral: Sham Retraining
Sham Comparator: Sham TDCS + Sham Retraining 0.1 mA of TDCS applied during sham alcohol avoidance retraining	Device: Sham TDCS; Behavioral: Sham Retraining

Outcome Measures

Primary Outcome Measures

1. Drinks Per Drinking Day [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction	Albuquerque	New Mexico	United States	87106

Sponsors and Collaborators

• The Mind Research Network
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Eric D Claus, Ph.D., Mind Research Network and LBERI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Mind Research Network
• ClinicalTrials.gov Identifier: NCT02045108
• Other Study ID Numbers: 20-520; 1R21AA021201-01A1
• First Posted: Jan 24, 2014
• Last Update Posted: Mar 20, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Binge Drinking

Study Results

Participant Flow

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of transcranial direct current stimulation (TDCS) applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Period Title: Overall Study
STARTED	22	15	20	20
COMPLETED	21	12	18	19
NOT COMPLETED	1	3	2	1

Baseline Characteristics

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining	Total
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining	Total of all reporting groups
Overall Participants	22	15	20	20	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.50 (2.70)	24.80 (2.78)	24.95 (2.80)	22.90 (1.92)	24.55 (2.71)
Sex: Female, Male (Count of Participants)
Female	8 36.4%	4 26.7%	6 30%	6 30%	24 31.2%
Male	14 63.6%	11 73.3%	14 70%	14 70%	53 68.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

At-risk alcohol drinkers ages 21-30

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	15	20	20
Mean (Standard Deviation) [drinks per drinking day]	6.1 (4.1)	6.8 (3.4)	6.6 (3.3)	7.5 (3.4)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	15	20	20
Mean (Standard Deviation) [milliseconds]	6.0 (84.6)	17.4 (114.9)	26.4 (110.0)	20.3 (111.9)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	15	20	20
Mean (Standard Deviation) [standard drinks per drinking day]	4.7 (2.6)	6.1 (2.8)	5.2 (2.6)	4.8 (2.7)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Two participants in the Active TDCS/Sham retraining and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	14	18	20
Mean (Standard Deviation) [standard drinks]	5.1 (2.2)	6.0 (2.8)	6.5 (3.5)	4.6 (2.0)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Two participant in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	13	18	19
Mean (Standard Deviation) [standard drinks]	5.8 (5.1)	5.5 (2.7)	5.5 (2.7)	5.0 (5.3)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	21	12	18	19
Mean (Standard Deviation) [standard drinks]	4.9 (2.9)	7.5 (3.4)	5.2 (4.3)	5.2 (2.2)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	21	12	18	19
Mean (Standard Deviation) [standard drinks]	5.7 (1.9)	6.5 (4.4)	5.9 (3.7)	5.1 (3.5)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Two participants in the Active TDCS/Active Retraining, four participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and three participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	20	11	18	17
Mean (Standard Deviation) [standard drinks]	4.5 (2.5)	6.6 (2.7)	5.7 (3.1)	5.5 (2.2)

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Three participants in the Sham TDCS/Active Retraining, one participant in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	12	19	19
Mean (Standard Deviation) [milliseconds]	41.6 (87.6)	143.6 (219.8)	51.9 (85.3)	66.6 (102.6)

10. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Measure Participants	22	15	20	20
Mean (Standard Deviation) [drinks per drinking day]	5.7 (1.9)	5.5 (2.9)	6.2 (3.6)	6.1 (4.0)

Adverse Events

Arm/Group Title	Active TDCS + Active Retraining		Sham TDCS + Active Retraining		Active TDCS + Sham Retraining		Sham TDCS + Sham Retraining
Arm/Group Description	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS		.1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS		2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining		0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
All Cause Mortality
	Active TDCS + Active Retraining		Sham TDCS + Active Retraining		Active TDCS + Sham Retraining		Sham TDCS + Sham Retraining
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/15 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Active TDCS + Active Retraining		Sham TDCS + Active Retraining		Active TDCS + Sham Retraining		Sham TDCS + Sham Retraining
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/15 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Active TDCS + Active Retraining		Sham TDCS + Active Retraining		Active TDCS + Sham Retraining		Sham TDCS + Sham Retraining
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)		1/15 (6.7%)		1/20 (5%)		0/20 (0%)
Skin and subcutaneous tissue disorders
Redness at stimulation site	2/22 (9.1%)	2	1/15 (6.7%)	1	1/20 (5%)	1	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.