Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedStudy Start
First participant enrolled
October 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 5, 2025
November 1, 2025
9 months
September 17, 2025
November 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Inhibition Failures (p-failures)
Change in the proportion of inhibition failures (p-failures) on the cued Go/NoGo task from baseline to post-intervention under each experimental condition. Higher p-failure rates reflect poorer inhibitory control. This outcome will be measured following each TMS and alcohol condition (iTBS, cTBS, sham Ă— active or placebo alcohol), and assessed across timepoints (peak Blood Alcohol Concentration (BAC) \~0.08% and descending BAC \~0.05%).
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)
Secondary Outcomes (2)
Reaction Time on Go Trials
Measured at baseline, at peak BAC, and on the descending limb of BAC (approximately 3 hours total)
Change in Blood Alcohol Concentration-related Task Performance
Assessed within-session at peak and descending BAC (approximately 3 hours total)
Study Arms (2)
Active alcohol
EXPERIMENTALParticipants 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 alcohol
PLACEBO COMPARATORParticipants 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 (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 (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 (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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Wesley, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- This is a study with five experimental conditions that are combinations of alcohol (real, placebo) and brain stimulation (real and sham). The participant will be blinded to all alcohol conditions (alcohol = single blind). The participant and experimenter will be blinded to the brain stimulation condition (TMS = double blinded).
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 17, 2025
First Posted
September 23, 2025
Study Start
October 30, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 5, 2025
Record last verified: 2025-11