TerminatedNot Applicable

Flexibility, Alcohol Misuse, and Excitation

Stopped: The study was terminated due to the death of the Principal Investigator.

United States7 participantsStarted 2024-07-18

Plain-language summary

The goal of this study is to learn whether a single non-invasive brain stimulation alpha-transcranial alternating current stimulation (alpha-tACS) session changes measures of excitability in the prefrontal cortex. It will also learn whether these changes predict differences in habitual action selection in a laboratory task and whether the effects depend on alcohol use history. The main questions it aims to answer are: Does alpha-tACS reduce habitual action selection by reducing excitability in the prefrontal cortex? Is alpha-tACS most effective in reducing habitual action selection in hazardous drinkers who engaged in binge-drinking during adolescence? Researchers will compare alpha-tACS to sham stimulation to see if alpha-tACS changes habitual action selection by changing prefrontal excitability. Participants will: Visit the lab for behavioral training Visit the imaging center for an MRI session Visit the lab to receive alpha-tACS or sham stimulation during behavioral testing and undergo EEG recordings before and after stimulation Visit the imaging center for a repeat MRI session Provide a small sample of blood from a finger-prick in the first and last visits.

Who can participate

Age range

22 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • 22-50 years old * Have a high school diploma or equivalent * Medically healthy * Fluent in English For RISK group only: * High risk alcohol use in the past month \[World Health Organization (WHO ) risk level 2-4\] * No history of adolescent binge drinking For RISK+ Adolescent binge alcohol (AIE) group only: * High risk alcohol use in the past month (WHO risk level 2-4) * High levels of adolescent alcohol use (4 or more binge drinking episodes before age 18) For Control (CON) group only: * Low risk alcohol use throughout the lifetime (WHO risk level 0-1) * No history of adolescent binge drinking * No lifetime history of Alcohol Use Disorder (AUD) Exclusion Criteria: * Any individual who meets one or more of the following criteria will be excluded from participation \[excluding positive breath alcohol concentration (BAC), urine drug screen, psychiatric diagnoses, and color blindness, all will be self-reported\]: * Lifetime history of a substance use disorder (SUD; including nicotine) but participants will not be excluded for an AUD. * Neurological disease such as dementia, seizures or head trauma * History of psychosis or psychotic episodes * Diagnosis of attention deficit hyperactivity disorder (ADHD) * Any systemic or inflammatory disease that could affect cognitive functioning (e.g., cancer, cardiovascular disease) * Any motor or visual disturbances that could hinder task performance (e.g., color blindness) * Use of psyc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Proportion of Errors

Timeframe: Pre-stimulation (Session 2) up to 2 weeks before, post-stimulation (Session 3), immediately after

Change in Prefrontal GABA:Glutamate/Glutamine Ratio

Timeframe: Pre-stimulation (Session 2) up to 2 weeks before, post-stimulation (Session 3), immediately after

Trial details

NCT IDNCT06634771

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-24

Results submitted2026-01-22

View on ClinicalTrials.gov More Behavioral Flexibility trials