Alcohol Risk BehaviorsNCT07188376
Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation
A study testing Intermittent Theta Burst Stimulation and Continuous Theta Burst Stimulation in people with Alcohol Risk Behaviors, run by Michael J. Wesley, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Risk Behaviors
- What is being tested?
- Intermittent Theta Burst Stimulation and Continuous Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40507
Michael J. Wesley, Ph.D., 8593231332, michael.wesley@uky.edu
About this study
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?
Read more
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.
Read the 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:
- Alcohol + iTBS
- Alcohol + cTBS
- Placebo drink + iTBS
- Placebo drink + cTBS
- 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
- Being tested
- Intermittent Theta Burst Stimulation, Continuous Theta Burst Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- TMS, Impulsivity
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
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 StimulationDevice
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 StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Active alcohol | Experimental | 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. Receives: Device: Intermittent Theta Burst Stimulation; Device: Continuous Theta Burst Stimulation; Device: Sham Transcranial Magnetic Stimulation |
| Placebo alcohol | Placebo comparator | 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. Receives: Device: Intermittent Theta Burst Stimulation; Device: Continuous Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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
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.
Measured: 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.
Measured: Assessed within-session at peak and descending BAC (approximately 3 hours total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Risk BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant completes all five conditions (Alcohol + iTBS, Alcohol + cTBS, Placebo + iTBS, Placebo + cTBS, and Alcohol + sham)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Wesley, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J. Wesley, PhD, University of Kentucky
- Investigators
- Michael Wesley, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188376
- Sponsor's protocol ID
- 106047
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07188376
- Acronym / sponsor ID
- 106047
- Conditions
- Alcohol Risk Behaviors
- Keywords
- TMS, Impulsivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Michael J. Wesley, PhDUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Alcohol + iTBS
- Alcohol + cTBS
- Placebo drink + iTBS
- Placebo drink + cTBS
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant completes all five conditions (Alcohol + iTBS, Alcohol + cTBS, Placebo + iTBS, Placebo + cTBS, and Alcohol + sham)
| Arm | Type | Receives |
|---|---|---|
| Active alcohol | Experimental | Device: Intermittent Theta Burst Stimulation, Device: Continuous Theta Burst Stimulation, Device: Sham Transcranial Magnetic StimulationParticipants 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 comparator | Device: Intermittent Theta Burst Stimulation, Device: Continuous Theta Burst StimulationParticipants 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. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Theta Burst StimulationIntermittent 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 | Active alcohol, Placebo alcohol |
| Continuous Theta Burst StimulationContinuous 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 | Active alcohol, Placebo alcohol |
| Sham Transcranial Magnetic StimulationSham 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. | Device | Active alcohol |
Primary outcome
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)
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%).
2 secondary outcomes
Reaction Time on Go Trials
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
Time frame: Assessed within-session at peak and descending BAC (approximately 3 hours total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Wesley, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation and Continuous Theta Burst Stimulation in people with Alcohol Risk Behaviors, run by Michael J. Wesley, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J. Wesley, Ph.D. (18593231332, michael.wesley@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.