Investigating brain stimulation effects on alcohol misuse and behavior
Frontal E/I Balance Mediation of TACS Effects on Behavioral Flexibility
This study is testing if a special brain stimulation can help people who drink too much make better choices about their drinking habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 22 Years to 50 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06634771 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of a single session of non-invasive brain stimulation, specifically alpha-transcranial alternating current stimulation (alpha-tACS), on the excitability of the prefrontal cortex and its influence on habitual action selection. Participants will be divided into three groups based on their alcohol use history: high-risk drinkers with and without a history of adolescent binge drinking, and low-risk drinkers. The study will involve behavioral training, MRI scans, and EEG recordings to assess changes in brain activity and behavior. By comparing the effects of true stimulation versus sham stimulation, researchers hope to understand the relationship between alcohol misuse and behavioral flexibility.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22-50 with varying levels of alcohol use, specifically those classified as high-risk drinkers or low-risk drinkers without a history of adolescent binge drinking.
Not a fit: Patients with a lifetime history of substance use disorders or those who do not meet the specified alcohol use criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new non-invasive interventions for individuals struggling with alcohol misuse and inflexible behavior.
How similar studies have performed: While the specific approach of using alpha-tACS in this context is novel, previous studies have shown promising results with brain stimulation techniques in modifying behavior related to substance use.
Eligibility criteria
Show full inclusion / exclusion criteria
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 psychoactive recreational drugs in the past month (excluding caffeine and alcohol) * Use of psychotropic medications in the past month including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics (excluding antidepressant use when dosage has been stable for 1 month or longer) * Use of therapeutic brain stimulation \[e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)\] in the past month * Any history of brain surgery * History of migraine headaches * Pregnancy * Any brain implants or devices * First degree relative with primary epilepsy * Claustrophobia * Any magnetic resonance imaging (MRI) contraindication based on the University of North Carolina Biomedical Research Imaging Center's MRI safety checklist * Breath alcohol above 0.0% at time of session * Positive urine drug screen at time of session If a participant should have an exclusion criterion arise in the course of their participation (e.g. pregnancy or psychotic episode), their participation in the study will end unless the circumstances are transitory in nature (e.g. positive breath alcohol or urine drug screen).
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Charlotte A Boettiger, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Charlotte A Boettiger, PhD
- Email: cab@unc.edu
- Phone: 919-962-2119
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.