Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation

Conditions

• Alcohol Risk Behaviors

Eligibility Criteria

Sex

ALL

Age

21 Years - 29 Years

Healthy Volunteers

Accepted

Interventions

• Intermittent Theta Burst Stimulation — DEVICE
  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 — DEVICE
  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 — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 30, 2025

Status verified

Nov 2025

Primary completion

Aug 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

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.

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

• Michael J. Wesley, Ph.D.
  18593231332
  [email protected]
• Mark T. Fillmore, Ph.D.
  18592574728
  [email protected]

Locations (1)

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