Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation

Summary

The goal of this clinical trial is to learn how a specific type of brain stimulation affects alcohol-related decision-making and self-control in adults who drink alcohol. The main questions the study aims to answer are:

* Does brain stimulation change how people behave after drinking alcohol?
* Does the combination of alcohol and different types of brain stimulation affect people's ability to make thoughtful decisions or resist impulses?

Researchers will compare the effects of two types of brain stimulation, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), after people drink alcohol or a placebo drink. A sham (placebo) stimulation condition will also be included. The study uses a within-person design, which means each participant will take part in all conditions.

Participants will:

* Attend five separate study visits
* Drink either an alcoholic or placebo beverage
* Receive one of the brain stimulation conditions (real or sham)
* Complete decision-making tasks before and after drinking

The tasks will measure things like impulsive choices and reaction time. The researchers hope this study will help identify how brain stimulation could be used to improve decision-making during intoxication, which might one day reduce harmful drinking behaviors or prevent alcohol-related accidents.

Conditions

• Alcohol Risk Behaviors

Interventions

DEVICE

Intermittent Theta Burst Stimulation

Intermittent Theta Burst Stimulation (iTBS) is then delivered to the left DLPFC using a MagVenture TMS device. Each iTBS session includes 600 pulses delivered in 3-pulse bursts at 50 Hz, every 200 ms (5 Hz), in 2 sec on / 8 sec off cycles at 110% resting motor threshold (RMT). Stimulation is ramp-up from 80% to 110% RMT (\~90 pulses). Two iTBS sessions are given per visit, separated by 30 minutes. The second session is timed to correspond to the peak BAC.

DEVICE

Continuous Theta Burst Stimulation

Continuous Theta Burst Stimulation (cTBS) is then delivered to the left DLPFC using a MagVenture TMS device. Each cTBS session includes 2 bouts of 1800 pulses separated by a 1 minute rest period. Each bout is delivered in 3-pulse bursts at 50 Hz, every 200 ms (5 Hz), continuously for \~120 seconds at 110% resting motor threshold (RMT). Stimulation is ramped up from 80% to 110% RMT over the first 30 seconds. Two cTBS sessions are given per visit, separated by 30 minutes. The second session is timed to correspond to the peak BAC.

DEVICE

Sham Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation (TMS) is delivered to the left DLPFC using the sham side of a MagVenture TMS coil, paired with synchronized scalp electrodes to mimic the sensation of real TMS. The sham procedure matches the timing and auditory cues of either iTBS or cTBS protocols, depending on random assignment. Two sham stimulation sessions are given per visit, separated by 30 minutes. The second session is timed to correspond to the peak BAC.

Sponsors & Collaborators

• Michael J. Wesley, PhD

  lead OTHER

Principal Investigators

• Michael Wesley, PhD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-30

Primary Completion

2026-08-01

Completion

2026-12-01

FDA Device

Yes

Countries

• United States

Study Locations