An interventional study of Intermittent Theta Burst Stimulation and Continuous Theta Burst Stimulation in Alcohol Risk Behaviors, sponsored by Michael J. Wesley, PhD. Recruiting at 1 site in United States. Open to participants aged 21 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Michael J. Wesley, PhD · Not applicable, Interventional, and Basic science
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:
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:
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.
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:
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:
Each session will be conducted on a separate day and will include:
The behavioral Go/No-Go Task will measure:
- How well participants can stop themselves from making automatic responses
The study's goals are to:
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.
158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 128 interventional studies indexed under Impulsive Behavior.
Browse Impulsive Behavior studies →Michael J. Wesley, PhD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Intermittent Theta Burst Stimulation · Device: Continuous Theta Burst Stimulation · Device: Sham Transcranial Magnetic Stimulation
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.
Device: Intermittent Theta Burst Stimulation · Device: Continuous 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 (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.
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 × active or placebo alcohol), and assessed across timepoints (peak Blood Alcohol Concentration (BAC) \~0.08% and descending BAC \~0.05%).
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)
Reaction Time on Go Trials
Average response latency (in milliseconds) to correctly identified Go stimuli on the cued Go/NoGo task. This measure reflects psychomotor speed and processing efficiency and will be used to assess general effects of alcohol and/or TMS interventions.
Time frame: 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
Exploratory analysis of behavioral changes (e.g., p-failures, Go reaction times) across different phases of the blood alcohol curve (peak \~0.08% vs. descending \~0.05%) under each intervention condition. This outcome will assess whether effects of TMS on inhibitory control and response latency are state-dependent relative to the intoxication curve.
Time frame: Assessed within-session at peak and descending BAC (approximately 3 hours total)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 19 months after the start.
Of 55 non-industry interventional studies with no phase under Impulsive Behavior, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 34. This study's planned 19 months is below that.
Counting every sponsor, half of 55 studies reached it within 26 months; a quarter within 13 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Michael J. Wesley, PhD