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Behavioural Intervention

tDCS + Cognitive Training for Alcoholism (tDCS/AUD Trial)

N/A

Recruiting

Led By Kelvin O Lim, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women 22-65 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention

Summary

This trial seeks to find out if a new treatment for Alcohol Use Disorder (AUD) can help reduce relapse rates. By combining cognitive training with transcranial direct current stimulation (tDCS), they hope to find a way to help those with AUD overcome their difficulties.

Who is the study for?

This trial is for Veterans aged 22-65 with Alcohol Use Disorder who are receiving outpatient care and have been sober for at least a week. They must be able to consent, not in acute withdrawal, on stable medication doses, and without significant risks from participating or conditions that could affect the study's integrity.

What is being tested?

The study tests if Active Transcranial Direct Current Stimulation (tDCS) paired with cognitive training can improve cognition in those with Alcohol Use Disorder better than a sham tDCS. It aims to see if this method strengthens brain networks and helps recovery.

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling during stimulation, headache, fatigue, nausea or insomnia. However, these are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 22 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Stroop Color-Word Test (SCWT) score

Change in Trail Making Test (TMT) score

Change in binge drinking days per week as measured using the Timeline Followback questionnaire

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: tDCS with Cognitive TrainingExperimental Treatment1 Intervention

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)

Group II: Sham tDCS with Cognitive TrainingPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Transcranial Direct Current Stimulation (tDCS)

2020

N/A

~160

0 / 1Eligibility criteria met