Alcohol Use DisordertDCS/AUDNCT04574167
Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Alcohol Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe Alcohol Use Disorder, according to DSM-5 within 12 months of enrollment (Participants may have current comorbid drug use, but their primary substance use disorder (SUD) diagnosis needs to be alcohol use based on self-report.)
- Veterans receiving outpatient clinical care services through the MVAHCS
- Abstinent from alcohol use for at least one week prior to the baseline study visit (Visit 1) (i.e., not in acute withdrawal) (Abstinence will be determined primarily via self-report, supplemented by breathalyzer, and clinical judgment based on other available data [e.g., perusal of medical records which may include urine test results and reports from clinicians in the Addiction Recovery Services Intensive Outpatient Program]).
- Men and women 22-70 years of age
- In the medical opinion of the PI, has been on a stable dose of all prescription and non-prescription medications (except for PRN medication) for at least 30 days prior to the baseline visit (Visit 1)
- Capable and willing to provide voluntary informed consent, in the medical opinion of the PI
Who cannot join
- Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results.
- Cognitive impairment as indicated by a score lower than or equal to 20 on the Montreal Cognitive Assessment (MoCA) or determined by the PI's judgment
- Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
- Participant answers YES to Question 3 and NO to Question 6 (Moderate Risk) or participant answers YES to Question 4, 5, or 6 (High Risk) on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp, presence of pacemakers, cochlea implants, or metal implants (excluding standard orthodontic braces, fillings, etc.))
- Contraindications for MRI (e.g., unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, significant breathing or movement disorder, claustrophobia) as assessed by completing the UMN CMRR Subject Safety Screening Form
- A positive pregnancy test result in a woman of childbearing age/potential as agreed upon by the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year.
Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. These cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.
- Conditions
- Alcohol Use Disorder
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
| Study group | Role | What they receive |
|---|---|---|
| tDCS with Cognitive Training | Experimental | Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes) Receives: Device: Active Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS with Cognitive Training | Sham comparator | Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in change in frontal-striatal functional connectivity
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over a 12-minute scan in order to gather resting state functional connectivity (RSFC). Hierarchical linear models will examine differences in change in target engagement (frontal-striatal RSFC) between active and sham tDCS conditions.
Measured: Change between baseline and post-intervention (3 week) follow-up
Change in Trail Making Test (TMT) score
The TMT is a neuropsychological test of visual attention and task switching. The test consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility and executive functioning.
Measured: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Change in Stroop Color-Word Test (SCWT) score
The SCWT is a neuropsychological test of the ability to inhibit cognitive interference which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Measured: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Change in binge drinking days per week as measured using the Timeline Followback questionnaire
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. Binge drinking is defined as men consuming 5 or more drinks or women consuming 4 or more drinks in about 2 hours.
Measured: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2020
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a double-blind, randomized, placebo (sham) controlled study of Veterans with AUD who will receive cognitive training and be randomized to either active or sham tDCS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Minneapolis Veterans Affairs Medical Center, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Kelvin O Lim, MD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574167
- Sponsor's protocol ID
- MHBB-011-19S
- Other IDs
- VAM-19-00460, 1594744
- Acronym
- tDCS/AUD
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2020
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified data may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
- ClinicalTrials.gov ID
- NCT04574167
- Acronym / sponsor ID
- tDCS/AUD / MHBB-011-19S
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Minneapolis Veterans Affairs Medical Center, University of Minnesota
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year.
Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. These cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a double-blind, randomized, placebo (sham) controlled study of Veterans with AUD who will receive cognitive training and be randomized to either active or sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| tDCS with Cognitive Training | Experimental | Device: Active Transcranial Direct Current Stimulation (tDCS)Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes) |
| Sham tDCS with Cognitive Training | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of moderate to severe Alcohol Use Disorder, according to DSM-5 within 12 months of enrollment (Participants may have current comorbid drug use, but their primary substance use disorder (SUD) diagnosis needs to be alcohol use based on self-report.)
- Veterans receiving outpatient clinical care services through the MVAHCS
- Abstinent from alcohol use for at least one week prior to the baseline study visit (Visit 1) (i.e., not in acute withdrawal) (Abstinence will be determined primarily via self-report, supplemented by breathalyzer, and clinical judgment based on other available data [e.g., perusal of medical records which may include urine test results and reports from clinicians in the Addiction Recovery Services Intensive Outpatient Program]).
- Men and women 22-70 years of age
- In the medical opinion of the PI, has been on a stable dose of all prescription and non-prescription medications (except for PRN medication) for at least 30 days prior to the baseline visit (Visit 1)
Key exclusion criteria (6 listed)
- Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results.
- Cognitive impairment as indicated by a score lower than or equal to 20 on the Montreal Cognitive Assessment (MoCA) or determined by the PI's judgment
- Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
- Participant answers YES to Question 3 and NO to Question 6 (Moderate Risk) or participant answers YES to Question 4, 5, or 6 (High Risk) on the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp, presence of pacemakers, cochlea implants, or metal implants (excluding standard orthodontic braces, fillings, etc.))
- Contraindications for MRI (e.g., unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, significant breathing or movement disorder, claustrophobia) as assessed by completing the UMN CMRR Subject Safety Screening Form
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 Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes. | Device | tDCS with Cognitive Training |
| Sham Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session). | Device | Sham tDCS with Cognitive Training |
Primary outcome
Differences in change in frontal-striatal functional connectivity
Time frame: Change between baseline and post-intervention (3 week) follow-up
Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over a 12-minute scan in order to gather resting state functional connectivity (RSFC). Hierarchical linear models will examine differences in change in target engagement (frontal-striatal RSFC) between active and sham tDCS conditions.
Change in Trail Making Test (TMT) score
Time frame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
The TMT is a neuropsychological test of visual attention and task switching. The test consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility and executive functioning.
Change in Stroop Color-Word Test (SCWT) score
Time frame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
The SCWT is a neuropsychological test of the ability to inhibit cognitive interference which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.
Change in binge drinking days per week as measured using the Timeline Followback questionnaire
Time frame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. Binge drinking is defined as men consuming 5 or more drinks or women consuming 4 or more drinks in about 2 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Deidentified data may be shared upon request.
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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.
Kelvin O Lim, MD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
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 Transcranial Direct Current Stimulation (tDCS) in people with Alcohol Use Disorder, run by VA Office of Research and Development 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 6 inclusion and 6 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 13 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in change in frontal-striatal functional connectivity (time frame: Change between baseline and post-intervention (3 week) follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.