New treatment using robot-guided magnetic stimulation for alcohol use disorder

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 is testing a novel treatment called image-guided, robot navigated transcranial magnetic stimulation (IR-TMS) to help individuals with alcohol use disorder (AUD) reduce their drinking. Participants will be randomly assigned to one of three treatment groups, each targeting different areas of the brain based on personalized fMRI connectivity maps. The treatment involves multiple sessions of IR-TMS, along with brain scans and assessments of drinking behavior and mental health. The goal is to evaluate the effectiveness and durability of this innovative approach compared to traditional therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Two self-reported heavy drinking episodes (\>4 drinks for men, \>3 for women) or \>13 drinks in the last 14 days (at screening)
2. PEth \>20 ng/mL (at baseline)
3. Diagnosis of a current, moderate to severe AUD assessed by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use checklist
4. Able to attend all study appointments
5. Fluent in English

Exclusion Criteria:

1. Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
2. Inability to provide informed consent
3. Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
4. Currently enrolled in AUD treatment
5. Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
6. Any history or signs of serious medical or neurological illness including seizure disorders
7. History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
8. Liver enzymes that are more than 5x the normal range
9. Females will be excluded if they are pregnant
10. Any history or signs of metal objects in the body deemed unsafe for Magnetic Resonance Imaging (MRI) or that may adversely affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers, metal implants, etc.)

Where it's running

• Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Brett C Ginsburg, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Brett C Ginsburg, PhD
• Email: ginsburg@uthscsa.edu
• Phone: 210-567-0871

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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.