Recruiting

iTBS & cTBS

Sponsor:

Michael J. Wesley, PhD

Code:

NCT07188376

Conditions

Alcohol Risk Behaviors

Eligibility Criteria

Sex: All

Age: 21 - 29

Healthy Volunteers: Accepted

Interventions

Intermittent Theta Burst Stimulation

Continuous Theta Burst Stimulation

Sham Transcranial Magnetic Stimulation

Study Details

Brief 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

Study ID

NCT07188376

Start date

Oct 30, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 29

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 21-29
  • Must be competent in English
  • BMI between 19 and 26
  • At least a high school education
  • Moderate alcohol users (e.g., at least occasional alcohol use, without meeting criteria for alcohol use disorder)
  • Negative urine drug screen for illicit drugs
  • Negative urine pregnancy test (if applicable) on testing days

Exclusion Criteria:

  • History of seizures or a first-degree relative with seizure history
  • History of head trauma or other CNS injuries
  • Current or past psychiatric disorders (including substance use disorder, except nicotine or caffeine)
  • Contraindications for non-invasive brain stimulation (e.g., metal implants, pacemaker)
  • Currently pregnant or breastfeeding
  • Current use of medications that lower seizure threshold
  • Positive alcohol withdrawal symptoms
  • Smokes more than five cigarettes per day (to avoid acute nicotine effects or withdrawal during visits)

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active alcohol

Participants consume a real alcoholic beverage (ethanol diluted 1:3 with soda, consumed over 10 minutes) designed to produce a peak BAC of \~0.08%

Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.

placebo comparator: Placebo alcohol

Participants consume a placebo beverage matched in volume and appearance to the alcoholic beverage, but without an intoxicating dose (soda with alcohol misted on top to simulate scent, consumed over 10 minutes).

Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Inhibition Failures (p-failures) [ Time Frame: Measured at baseline, immediately after the second TMS session at peak BAC (~0.08%), and again on the descending limb of BAC (~0.05%) (approximately 3 hours total) ]

Central Contacts and Locations

Central contacts

Michael J. Wesley, Ph.D.

18593231332michael.wesley@uky.edu

Mark T. Fillmore, Ph.D.

18592574728Fillmore@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40507

Contacts

Michael J. Wesley, Ph.D.

8593231332michael.wesley@uky.edu

More Information

Sponsor

Michael J. Wesley, PhD

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • TMS
  • Impulsivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael J. Wesley, PhD on 2026-08-21.