NCT07188376

Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Michael J. Wesley, PhD · Academic / Other
• Sex: All
• Age: 21 Years – 29 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study aims to understand how brain stimulation affects decision-making and behavioral control after alcohol consumption. Many harmful events related to alcohol use are the result of impaired decision-making while intoxicated. Although there are medications that reduce alcohol cravings, there are few tools available to reduce the negative behavioral effects of alcohol once someone has already consumed it. This clinical trial uses non-invasive brain stimulation, known as transcranial magnetic stimulation (TMS), to target a brain area called the prefrontal cortex, which helps regulate decision-making and self-control. TMS can increase or decrease activity in targeted brain areas using magnetic pulses. Two specific types of stimulation will be tested: * iTBS (intermittent theta burst stimulation): typically increases brain activity * cTBS (continuous theta burst stimulation): typically decreases brain activity Participants will be healthy adults who report regularly drinking alcohol. Each participant will attend five sessions in a randomized, within-subject design. Across the sessions, participants will experience each of the following conditions: 1. Alcohol + iTBS 2. Alcohol + cTBS 3. Placebo drink + iTBS 4. Placebo drink + cTBS 5. Alcohol + sham (placebo) stimulation Each session will be conducted on a separate day and will include: * A baseline set of tasks (before drinking or stimulation) * Drinking either an alcoholic or placebo beverage * TMS delivered during the rise and peak of blood alcohol concentration * A second round of behavioral tasks administered at peak intoxication and again during the descending limb of the blood alcohol curve The behavioral Go/No-Go Task will measure: \- How well participants can stop themselves from making automatic responses The study's goals are to: * Test whether brain stimulation can reduce impulsive behaviors under the influence of alcohol * Understand the separate and combined effects of alcohol and TMS on decision-making * Identify which type of TMS is most effective in modulating intoxicated behavior The stimulation dose and session timing are designed to align with the typical rise and fall of blood alcohol levels. Each stimulation session will use a "ramping" protocol to gradually increase stimulation intensity, improving tolerability. Safety and tolerability will be carefully monitored. This study builds on previous work showing that TMS can influence decision-making but is the first to examine whether TMS can be used during alcohol intoxication to improve behavioral control. If successful, the findings may lead to new interventions for preventing risky or harmful behaviors associated with alcohol use.

Conditions

• Alcohol Risk Behaviors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-09-23
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study