Using brain stimulation to reduce alcohol cravings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of theta burst stimulation (TBS) applied to the medial prefrontal cortex (mPFC) on individuals with alcohol use disorder (AUD). Participants will undergo 36 sessions of either real or sham TBS over four weeks to assess changes in their drinking behavior and brain responses to alcohol-related cues. The study is designed as a double-blind, placebo-controlled, randomized trial, ensuring that neither the participants nor the researchers know who receives the active treatment. The ultimate goal is to determine if TBS can serve as an effective non-invasive treatment option for reducing alcohol consumption and cravings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\]
* 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.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Lisa M McTeague
• Email: mcteague@musc.edu
• Phone: 842-792-8274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.