Transcranial Magnetic Stimulation for Alcohol Risk Behaviors

Overseen By Mark T. Fillmore, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Michael J. Wesley, PhD

Must not be taking: Seizure threshold medications

Disqualifiers: Seizures, Head trauma, Psychiatric disorders, others

Compensation: Varies

Number of Visits: 5

Duration: 5 sessions

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a type of brain stimulation affects decision-making and self-control after alcohol consumption. It will compare intermittent and continuous theta burst stimulation to determine their effectiveness in reducing impulsive behavior when participants are intoxicated. Participants will attend multiple sessions, consuming either alcohol or a placebo, and undergo brain stimulation. The trial seeks moderate drinkers who speak English, have a BMI between 19 and 26, and do not have a history of seizures or psychiatric disorders. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on brain stimulation and its effects on behavior.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that lower the seizure threshold. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that this brain stimulation technique is safe for use in adults who drink alcohol?

Research has shown that continuous theta burst stimulation (cTBS) is generally well-tolerated. One study found that ten days of cTBS reduced alcohol consumption and decreased brain response to alcohol-related cues for up to three months, suggesting it might help with alcohol use without major side effects. Another study demonstrated that cTBS sessions safely affected brain function, as seen in MRI scans.

For intermittent theta burst stimulation (iTBS), research also indicates safety. Studies have shown that iTBS is as safe and effective as other brain stimulation treatments. In trials, it has not caused significant side effects, making it a promising option for those with alcohol use issues.

Both types of stimulation have been tested in various settings and have shown good safety profiles, meaning they are unlikely to cause harm. This makes them promising options for clinical trials focusing on alcohol-related behaviors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for alcohol risk behaviors because it targets the brain directly, which is a different approach from traditional treatments like counseling or medication. TMS involves applying magnetic fields to stimulate nerve cells in the brain, which could potentially reduce impulsivity associated with alcohol consumption. This technique is non-invasive and could offer a fast-acting alternative to existing treatments, which often take longer to show effects. By offering a method that works at the neurological level, TMS might provide a new pathway for helping individuals manage their alcohol-related behaviors more effectively.

What evidence suggests that this trial's brain stimulation treatments could be effective for improving decision-making during intoxication?

This trial will compare two types of brain stimulation, continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation (iTBS), to assess their effects on alcohol risk behaviors. Research has shown that cTBS can lower drinking levels and decrease the brain's reaction to alcohol cues for up to three months. Meanwhile, iTBS improved outcomes for people with alcohol use disorder by reducing symptoms of depression and the risk of relapse. Both cTBS and iTBS have proven safe and effective in addressing alcohol-related issues. This trial aims to determine if these brain stimulation methods can help people make better decisions and exercise more self-control in situations involving alcohol. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Wesley, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults with ADHD who also engage in risky alcohol behaviors. Participants will undergo brain stimulation after consuming alcohol or a placebo to see if it affects their decision-making and self-control.

Inclusion Criteria

Must be competent in English

BMI between 19 and 26

At least a high school education

Exclusion Criteria

Positive alcohol withdrawal symptoms

Current or past psychiatric disorders (including substance use disorder, except nicotine or caffeine)

Contraindications for non-invasive brain stimulation (e.g., metal implants, pacemaker)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend five separate study visits, consume either an alcoholic or placebo beverage, receive one of the brain stimulation conditions (real or sham), and complete decision-making tasks before and after drinking.

5 sessions

5 visits (in-person)

Follow-up

Participants are monitored for changes in impulsivity and decision-making after each session.

3 hours per session

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Theta Burst Stimulation
• Intermittent Theta Burst Stimulation
• Sham Transcranial Magnetic Stimulation

Trial Overview The study tests two types of brain stimulation: intermittent theta burst (iTBS) and continuous theta burst (cTBS), compared to sham stimulation, on decision-making and impulse control post-alcohol consumption using a within-person design over five visits.

How Is the Trial Designed?

Group I: Active alcohol Experimental Treatment 3 Interventions

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.

Group II: Placebo alcohol Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Michael J. Wesley, PhD

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6244710/

Continuous Theta Burst Transcranial Magnetic Stimulation of ... Poor response inhibition as a predictor of problem drinking and illicit drug use in adolescents at risk for alcoholism and other substance use disorders.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06060496

Theta Burst Stimulation for Alcohol Use Disorder The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667174322000271

Medial Prefrontal Cortex Theta Burst Stimulation Improves ... Ten days of MPFC TBS is well tolerated, reduces drinking, and decreases brain reactivity to alcohol cues for up to 3 months after treatment initiation.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09093-1

Theta Burst Stimulation as a tool to decrease drinking ... - Trials This outcome reflects the average number of alcoholic drinks consumed on days when drinking occurs and is a key indicator of treatment efficacy.

5. link.springer.com link.springer.com/article/10.1007/s11469-024-01261-9

a Focus on the Effects of Theta-Burst Stimulation Over ... This study included 58 participants diagnosed with GD or SUDs. They underwent bilateral pre-SMA continuous TBS (cTBS) sessions targeting craving, impulsivity, ...

6. link.springer.com link.springer.com/article/10.3758/s13415-021-00940-7

Elevated ad libitum alcohol consumption following ... Previous research indicates that following alcohol intoxication, activity in prefrontal cortices is reduced, linking to changes in associated cognitive ...

7. nature.com nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ... Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)