Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)
An Open-label Clinical Trial of IR-TMS for AUD and Development of a Neurobiological Biomarker for Craving and Relapse Validated Using a Direct Biochemical Biomarker (Phosphatidylethanol) of Alcohol Use
The University of Texas Health Science Center at San Antonio
150 participants
Feb 3, 2025
INTERVENTIONAL
Conditions
Summary
This study is testing a new treatment called IR-TMS (image-guided, robot navigated transcranial magnetic stimulation) to see if it can help people who drink too much alcohol to reduce the amount they drink. Participants will be placed into one of three groups, each receiving a slightly different version of this treatment. The study involves going through a few sessions of IR-TMS, having brain scans (MRI), providing blood and urine samples, and answering questions about their drinking and mental health. These activities are part of the study and aren't usually part of regular treatment for alcohol use. IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain. The goal is to see if this treatment can help reduce the urge to drink. There are other options, like sticking with therapy or medication, which are less intense but have been used for a longer time.
Eligibility
Inclusion Criteria5
- Two self-reported heavy drinking episodes (>4 drinks for men, >3 for women) or >13 drinks in the last 14 days (at screening)
- PEth >20 ng/mL (at baseline)
- 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
- Able to attend all study appointments
- Fluent in English
Exclusion Criteria10
- Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
- Inability to provide informed consent
- Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
- Currently enrolled in AUD treatment
- Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
- Any history or signs of serious medical or neurological illness including seizure disorders
- History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
- Liver enzymes that are more than 5x the normal range
- Females will be excluded if they are pregnant
- 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.)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
TMS applies a strong (\~2 Tesla), rapidly changing electro-magnetic field at the scalp to induce electrical current flow in underlying brain tissues
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06648642