Clinical trial NCT04574167: Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
Official title: Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Minneapolis Veterans Affairs Medical Center
name: University of Minnesota
First posted: 2020-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Differences in change in frontal-striatal functional connectivity
timeFrame: Change between baseline and post-intervention (3 week) follow-up
measure: Change in Trail Making Test (TMT) score
timeFrame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
measure: Change in Stroop Color-Word Test (SCWT) score
timeFrame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
measure: Change in binge drinking days per week as measured using the Timeline Followback questionnaire
timeFrame: Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Kelvin O Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: