Trial Outcomes & Findings for Cognitive Retraining and Brain Stimulation for Alcohol Use (NCT NCT02045108)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

Screening Visit

Results posted on

2018-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Active TDCS + Active Retraining 2.0 milliamps (mA) of transcranial direct current stimulation (TDCS) applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Overall Study STARTED	22	15	20	20
Overall Study COMPLETED	21	12	18	19
Overall Study NOT COMPLETED	1	3	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Retraining and Brain Stimulation for Alcohol Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining	Total n=77 Participants Total of all reporting groups
Age, Continuous	25.50 years STANDARD_DEVIATION 2.70 • n=5 Participants	24.80 years STANDARD_DEVIATION 2.78 • n=7 Participants	24.95 years STANDARD_DEVIATION 2.80 • n=5 Participants	22.90 years STANDARD_DEVIATION 1.92 • n=4 Participants	24.55 years STANDARD_DEVIATION 2.71 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	24 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	53 Participants n=21 Participants

PRIMARY outcome

Timeframe: Screening Visit

Population: At-risk alcohol drinkers ages 21-30

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	6.1 drinks per drinking day Standard Deviation 4.1	6.8 drinks per drinking day Standard Deviation 3.4	6.6 drinks per drinking day Standard Deviation 3.3	7.5 drinks per drinking day Standard Deviation 3.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Alcohol Approach Bias	6.0 milliseconds Standard Deviation 84.6	17.4 milliseconds Standard Deviation 114.9	26.4 milliseconds Standard Deviation 110.0	20.3 milliseconds Standard Deviation 111.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	4.7 standard drinks per drinking day Standard Deviation 2.6	6.1 standard drinks per drinking day Standard Deviation 2.8	5.2 standard drinks per drinking day Standard Deviation 2.6	4.8 standard drinks per drinking day Standard Deviation 2.7

PRIMARY outcome

Timeframe: 2 weeks post-baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=14 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=18 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	5.1 standard drinks Standard Deviation 2.2	6.0 standard drinks Standard Deviation 2.8	6.5 standard drinks Standard Deviation 3.5	4.6 standard drinks Standard Deviation 2.0

PRIMARY outcome

Timeframe: 3 weeks post-baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=13 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=18 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=19 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	5.8 standard drinks Standard Deviation 5.1	5.5 standard drinks Standard Deviation 2.7	5.5 standard drinks Standard Deviation 2.7	5.0 standard drinks Standard Deviation 5.3

PRIMARY outcome

Timeframe: 4 weeks post-baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=21 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=12 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=18 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=19 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	4.9 standard drinks Standard Deviation 2.9	7.5 standard drinks Standard Deviation 3.4	5.2 standard drinks Standard Deviation 4.3	5.2 standard drinks Standard Deviation 2.2

PRIMARY outcome

Timeframe: 5 weeks post-baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=21 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=12 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=18 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=19 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	5.7 standard drinks Standard Deviation 1.9	6.5 standard drinks Standard Deviation 4.4	5.9 standard drinks Standard Deviation 3.7	5.1 standard drinks Standard Deviation 3.5

PRIMARY outcome

Timeframe: 8 weeks post-baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=20 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=11 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=18 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=17 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	4.5 standard drinks Standard Deviation 2.5	6.6 standard drinks Standard Deviation 2.7	5.7 standard drinks Standard Deviation 3.1	5.5 standard drinks Standard Deviation 2.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=12 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=19 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=19 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Alcohol Approach Bias	41.6 milliseconds Standard Deviation 87.6	143.6 milliseconds Standard Deviation 219.8	51.9 milliseconds Standard Deviation 85.3	66.6 milliseconds Standard Deviation 102.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active TDCS + Active Retraining n=22 Participants 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 Participants .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 Participants 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 Participants 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Drinks Per Drinking Day	5.7 drinks per drinking day Standard Deviation 1.9	5.5 drinks per drinking day Standard Deviation 2.9	6.2 drinks per drinking day Standard Deviation 3.6	6.1 drinks per drinking day Standard Deviation 4.0

Adverse Events

Active TDCS + Active Retraining

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham TDCS + Active Retraining

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active TDCS + Sham Retraining

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham TDCS + Sham Retraining

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active TDCS + Active Retraining n=22 participants at risk 2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Active Retraining Active TDCS	Sham TDCS + Active Retraining n=15 participants at risk .1 mA of TDCS applied during active alcohol avoidance retraining Active Retraining Sham TDCS	Active TDCS + Sham Retraining n=20 participants at risk 2.0 mA of TDCS applied during sham alcohol avoidance retraining Active TDCS Sham Retraining	Sham TDCS + Sham Retraining n=20 participants at risk 0.1 mA of TDCS applied during sham alcohol avoidance retraining Sham TDCS Sham Retraining
Skin and subcutaneous tissue disorders Redness at stimulation site	9.1% 2/22 • Number of events 2	6.7% 1/15 • Number of events 1	5.0% 1/20 • Number of events 1	0.00% 0/20

Additional Information

Dr. Eric Claus

The Mind Research Network

Phone: 505-272-5028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place