Cognitive Retraining and Brain Stimulation for Alcohol Use

Conditions

Binge Drinking

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.

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Interventions

BEHAVIORALActive Retraining

DEVICESham TDCS

DEVICEActive TDCS

BEHAVIORALSham Retraining

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Active TDCS + Active Retraining 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	22
Sham TDCS + Active Retraining .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	15
Active TDCS + Sham Retraining 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	20
Sham TDCS + Sham Retraining 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining	20
Total	77

Baseline characteristics

Characteristic	Active TDCS + Active Retraining	Sham TDCS + Active Retraining	Active TDCS + Sham Retraining	Sham TDCS + Sham Retraining	Total
Age, Continuous	25.50 years STANDARD_DEVIATION 2.7	24.80 years STANDARD_DEVIATION 2.78	24.95 years STANDARD_DEVIATION 2.8	22.90 years STANDARD_DEVIATION 1.92	24.55 years STANDARD_DEVIATION 2.71
Sex: Female, Male Female	8 Participants	4 Participants	6 Participants	6 Participants	24 Participants
Sex: Female, Male Male	14 Participants	11 Participants	14 Participants	14 Participants	53 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 15	0 / 20	0 / 20
other Total, other adverse events	2 / 22	1 / 15	1 / 20	0 / 20
serious Total, serious adverse events	0 / 22	0 / 15	0 / 20	0 / 20

Outcome results

Primary

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.

Time frame: 1 week after treatment

Population: 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	Measure	Value (MEAN)	Dispersion
Active TDCS + Active Retraining	Alcohol Approach Bias	41.6 milliseconds	Standard Deviation 87.6
Sham TDCS + Active Retraining	Alcohol Approach Bias	143.6 milliseconds	Standard Deviation 219.8
Active TDCS + Sham Retraining	Alcohol Approach Bias	51.9 milliseconds	Standard Deviation 85.3
Sham TDCS + Sham Retraining	Alcohol Approach Bias	66.6 milliseconds	Standard Deviation 102.6

Primary

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Active TDCS + Active Retraining	Alcohol Approach Bias	6.0 milliseconds	Standard Deviation 84.6
Sham TDCS + Active Retraining	Alcohol Approach Bias	17.4 milliseconds	Standard Deviation 114.9
Active TDCS + Sham Retraining	Alcohol Approach Bias	26.4 milliseconds	Standard Deviation 110
Sham TDCS + Sham Retraining	Alcohol Approach Bias	20.3 milliseconds	Standard Deviation 111.9

Primary

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.

Time frame: Screening Visit

Population: At-risk alcohol drinkers ages 21-30

Arm	Measure	Value (MEAN)	Dispersion
Active TDCS + Active Retraining	Drinks Per Drinking Day	6.1 drinks per drinking day	Standard Deviation 4.1
Sham TDCS + Active Retraining	Drinks Per Drinking Day	6.8 drinks per drinking day	Standard Deviation 3.4
Active TDCS + Sham Retraining	Drinks Per Drinking Day	6.6 drinks per drinking day	Standard Deviation 3.3
Sham TDCS + Sham Retraining	Drinks Per Drinking Day	7.5 drinks per drinking day	Standard Deviation 3.4

Primary