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Theta Burst Stimulation for Alcohol Use Disorder

This study is testing a treatment called Theta Burst Stimulation (TBS) to see if it can help people with Alcohol Use Disorder (AUD). TBS is a type of transcranial magnetic stimulation (TMS), which uses magnetic pulses to gently stimulate a specific part of the brain called the medial prefrontal cortex (mPFC). Researchers believe this area of the brain is involved in drinking patterns. The study aims to find out if TBS can reduce the desire to drink alcohol and change how the brain reacts to alcohol-related images. You may be able to join if you are between 21 and 65 years old and have been diagnosed with Alcohol Use Disorder. The study will measure success by looking at changes in heavy drinking days, days without alcohol, and brain activity related to alcohol cues. The current status of this study is unclear.

Study design
This is a double-blind, placebo-controlled, randomized study, meaning neither you nor the researchers will know if you are receiving the real TBS or a sham (inactive) treatment. The study plans to enroll 86 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after treatment to assess changes in drinking patterns.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04998916

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Recruiting
NAAges 21–65InterventionalTreatment
Medical University of South Carolina
~86 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Real TBS to the mPFCSham TBS to the mPFC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Percent Heavy Drinking Days (PHDD) from baseline
Measured over Baseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3)
+2 more outcomes measured

Conditions

Alcohol Use Disorder
Alcohol Drinking
Substance Use
Drinking, Alcohol
Alcohol Use Disorder (AUD)

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
South Carolina1

Who to contact

Lisa M McTeague
[email protected]
842-792-8274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction)
Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V
Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.
Able to read and understand questionnaires and informed consent.
Has current suicidal ideation or homicidal ideation
Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.

Exclusion

Has metal placed above the neck
Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)
Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal
Has a history of claustrophobia
Has a history of chronic migraines
Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage
Has an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure)
Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric/sleeping medications except for stable (1 month) antidepressants/SSRI's. \[Note: this criterion is for scientific rather than safety or patient comfort reasons\].
Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months

What this trial measures

  • Change in Percent Heavy Drinking Days (PHDD) from baselineBaseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3)

    The primary outcome analysis will examine the TMS treatment effect (active vs. sham) on drinking outcomes-measured as percent heavy drinking days (PHDD) (heavy drinking day defined as 4 or more drinks for women and 5 or more drinks for men)-in the follow-up period beginning after the final treatment session. Collected via timeline follow back (TLFB) in three 28-day (month) intervals, this will be analyzed using multivariate mixture models to consider the effect of time (month after treatment) and the interaction of treatment with time, baseline drinking, number of treatment sessions received, and any other potential covariates (e.g., age, nicotine use, time since last drink). Drinking data will be collected on all randomized participants, irrespective of treatment completion. Lower percentages indicate fewer heavy drinking days in the 28-day interval.

  • Change in Percent Days Abstinent (PDA) from baselineBaseline (Week 1), Post-treatment (4-weeks from baseline), 1-month post treatment (Follow-up #1), 2-months post treatment (Follow-up #2), 3-months post treatment (Follow-up #3)

    The primary outcome analysis will examine the TMS treatment effect (active vs. sham) on drinking outcomes-measured as percent days abstinent (PDA) - in the follow-up period beginning after the final treatment session. Collected via timeline follow back (TLFB) in three 28-day (month) intervals, this will be analyzed using multivariate mixture models to consider the effect of time (month after treatment) and the interaction of treatment with time, baseline drinking, number of treatment sessions received, and any other potential covariates (e.g., age, nicotine use, time since last drink). Drinking data will be collected on all randomized participants, irrespective of treatment completion. Higher percentages indicate increased days abstinent from alcohol in the 28-day interval.

  • Change in alcohol cue task MRI activation 1-week post treatment from baselineBaseline (Week 1), Post-treatment (4-weeks from baseline)

    For the alcohol cue reactivity task, multivariate mixture model analyses will be used to calculate the difference in activation between the ALC and BEV blocks for vmPFC and ventral striatal ROIs, and to analyze maximum likelihood estimates for ALC vs. BEV activation as a function of time, treatment, and the cross-level interactions of these factors. Specifically, the cue task stimuli will be nested within time (post- vs. pre-treatment scan); time will be nested within participant; and participants will be nested within treatment (Sham vs. Active).