Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans (tDCS/AUD)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Device: Sham Transcranial Direct Current Stimulation (tDCS); Device: Active Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04574167

MHBB-011-19S

VAM-19-00460 (Other Identifier)

1594744 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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, 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

tDCS with Cognitive Training

Experimental group

Description:

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)

Treatment:

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS with Cognitive Training

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation (tDCS)