Using brain stimulation and cognitive training to help veterans with alcohol use disorder
Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
This study is testing whether a combination of brain stimulation and cognitive training can help veterans with alcohol use disorder stay sober and improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04574167 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial direct current stimulation (tDCS) combined with cognitive training on veterans suffering from Alcohol Use Disorder (AUD). The aim is to enhance cognitive function and strengthen brain networks associated with recovery, potentially reducing relapse rates. Participants will receive either active or sham tDCS while engaging in cognitive training exercises. The study focuses on veterans who have been abstinent from alcohol for at least one week prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 22-65 with a diagnosis of moderate to severe Alcohol Use Disorder who have been abstinent from alcohol for at least one week.
Not a fit: Patients who are not veterans or those who have not been abstinent from alcohol for the required period may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for veterans with alcohol use disorder by reducing relapse rates.
How similar studies have performed: Other studies have shown promise in using cognitive training and brain stimulation for addiction treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of moderate to severe Alcohol Use Disorder, according to DSM-5 within 6 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 22-65 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kelvin O Lim, MD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Megan Kazynski, MS
- Email: megan.kazynski@va.gov
- Phone: (612) 467-4140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.