Binge DrinkingNCT02045108

Cognitive Retraining and Brain Stimulation for Alcohol Use

A study testing Active Retraining and Active TDCS in people with Binge Drinking, run by The Mind Research Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 30 years
Conditions the study is for: Binge Drinking
What is being tested?: Active Retraining and Active TDCS
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 30 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

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Left handed
Prior participation in a brain stimulation study
Implanted brain medical devices
Electromedical devices
Latex allergy

Trial locations and contacts

1 site in 1 country.

United States1 site

The Mind Research Network and University of New Mexico Center on Alcoholism, Substance Abuse and Addiction
Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining

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.

Conditions: Binge Drinking
Being tested: Active Retraining, Sham TDCS, Active TDCS, Sham Retraining
Medical subject headings: Binge Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active RetrainingBehavioural
Sham TDCSDevice
Active TDCSDevice
Sham RetrainingBehavioural

Study groups in NCT02045108
Study group	Role	What they receive
Active TDCS + Active Retraining	Experimental	2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining Receives: Behavioral: Active Retraining; Device: Active TDCS
Sham TDCS + Active Retraining	Experimental	.1 mA of TDCS applied during active alcohol avoidance retraining Receives: Behavioral: Active Retraining; Device: Sham TDCS
Active TDCS + Sham retraining	Experimental	2.0 mA of TDCS applied during sham alcohol avoidance retraining Receives: Device: Active TDCS; Behavioral: Sham Retraining
Sham TDCS + Sham Retraining	Sham comparator	0.1 mA of TDCS applied during sham alcohol avoidance retraining Receives: Device: Sham TDCS; Behavioral: Sham Retraining

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Screening Visit
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.
Measured: Baseline
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.
Measured: 1 week post-baseline
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.
Measured: 2 weeks post-baseline
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.
Measured: 3 weeks post-baseline
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.
Measured: 4 weeks post-baseline
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.
Measured: 5 weeks post-baseline
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.
Measured: 8 weeks post-baseline
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.
Measured: 1 week after treatment
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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Dec 2015

First posted24 Jan 2014 (estimated)
Study startJan 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Binge DrinkingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02045108
Sponsor's protocol ID: 20-520
Other IDs: 1R21AA021201-01A1
Status last verified: Mar 2018
First submitted: 20 Jan 2014
Last updated: 20 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Binge Drinking trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modifying Alcohol Approach Motivations With tDCS and Cognitive Retraining
ClinicalTrials.gov ID: NCT02045108
Acronym / sponsor ID: 20-520
Conditions: Binge Drinking
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: The Mind Research NetworkUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Jan 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 24 Jan 2014 (estimated)
Results: Posted 20 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Active TDCS + Active Retraining	Experimental	Behavioral: Active Retraining, Device: Active TDCS2.0 milliamps (mA) of TDCS applied during active alcohol avoidance retraining
Sham TDCS + Active Retraining	Experimental	Behavioral: Active Retraining, Device: Sham TDCS.1 mA of TDCS applied during active alcohol avoidance retraining
Active TDCS + Sham retraining	Experimental	Device: Active TDCS, Behavioral: Sham Retraining2.0 mA of TDCS applied during sham alcohol avoidance retraining
Sham TDCS + Sham Retraining	Sham comparator	Device: Sham TDCS, Behavioral: Sham Retraining0.1 mA of TDCS applied during sham alcohol avoidance retraining

Who may qualify

Ages: 21 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Retraining	Behavioural	Active TDCS + Active Retraining, Sham TDCS + Active Retraining
Sham TDCS	Device	Sham TDCS + Active Retraining, Sham TDCS + Sham Retraining
Active TDCS	Device	Active TDCS + Active Retraining, Active TDCS + Sham retraining
Sham Retraining	Behavioural	Active TDCS + Sham retraining, Sham TDCS + Sham Retraining

Primary outcome

Drinks Per Drinking Day
Time frame: 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
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.
Alcohol Approach Bias
Time frame: 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.
Drinks Per Drinking Day
Time frame: 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.

Results and safety

Results posted to the registry on 20 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active TDCS + Active Retraining	22	21
Sham TDCS + Active Retraining	15	12
Active TDCS + Sham Retraining	20	18
Sham TDCS + Sham Retraining	20	19

Primary outcome: Drinks Per Drinking Day

Time frame: Screening Visit. Mean (Standard Deviation). Unit: drinks per drinking day

Measure	Active TDCS + Active Retraining n = 22	Sham TDCS + Active Retraining n = 15	Active TDCS + Sham Retraining n = 20	Sham TDCS + Sham Retraining n = 20
Value	6.1 (4.1)	6.8 (3.4)	6.6 (3.3)	7.5 (3.4)

Population analysed: At-risk alcohol drinkers ages 21-30

Primary outcome: Alcohol Approach Bias

Time frame: Baseline. Mean (Standard Deviation). Unit: milliseconds

Measure	Active TDCS + Active Retraining n = 22	Sham TDCS + Active Retraining n = 15	Active TDCS + Sham Retraining n = 20	Sham TDCS + Sham Retraining n = 20
Value	6.0 (84.6)	17.4 (114.9)	26.4 (110.0)	20.3 (111.9)

Primary outcome: Drinks Per Drinking Day

Time frame: 1 week post-baseline. Mean (Standard Deviation). Unit: standard drinks per drinking day

Measure	Active TDCS + Active Retraining n = 22	Sham TDCS + Active Retraining n = 15	Active TDCS + Sham Retraining n = 20	Sham TDCS + Sham Retraining n = 20
Value	4.7 (2.6)	6.1 (2.8)	5.2 (2.6)	4.8 (2.7)

Primary outcome: Drinks Per Drinking Day

Time frame: 2 weeks post-baseline. Mean (Standard Deviation). Unit: standard drinks

Measure	Active TDCS + Active Retraining n = 22	Sham TDCS + Active Retraining n = 14	Active TDCS + Sham Retraining n = 18	Sham TDCS + Sham Retraining n = 20
Value	5.1 (2.2)	6.0 (2.8)	6.5 (3.5)	4.6 (2.0)

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TDCS + Active Retraining	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22
Sham TDCS + Active Retraining	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Active TDCS + Sham Retraining	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Sham TDCS + Sham Retraining	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Binge Drinking

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric D Claus, Ph.D. principal investigator

Mind Research Network and LBERI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Retraining and Active TDCS in people with Binge Drinking, run by The Mind Research Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drinks Per Drinking Day (time frame: Screening Visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02045108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.