Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)

Last updated: February 20, 2025
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Use Disorder

Addictions

Substance Abuse

Treatment

Transcranial Magnetic Stimulation (TMS)

Clinical Study ID

NCT06648642
STUDY00000467
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Two self-reported heavy drinking episodes (>4 drinks for men, >3 for women) or >13drinks 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 andStatistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance usechecklist

  4. Able to attend all study appointments

  5. Fluent in English

Exclusion

Exclusion Criteria:

  1. Current diagnosis of a moderate or severe substance use disorder (SUD; other thanAUD, 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 diagnostichistory of bipolar disorder, schizophrenia or schizoaffective disorder

  6. Any history or signs of serious medical or neurological illness including seizuredisorders

  7. History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes ormore

  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 MagneticResonance Imaging (MRI) or that may adversely affect image quality of the brainregion (e.g. surgical clips, cardiac pacemakers, metal implants, etc.)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation (TMS)
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
May 31, 2027

Study Description

Participants with AUD will undergo accelerated IR-TMS treatments and longitudinal fMRI scanning to determine treatment effects and durability. Participants will be recruited and randomized to 1 of 3 treatment target site regions: 1) Left dorsolateral prefrontal cortex; 2) Dorsomedial prefrontal cortex; or 3) Orbitofrontal Cortex. Each participant's target site region will be determined by personalized fMRI connectivity maps. Participants will receive up to 4 IR-TMS treatments per day for up to 10 days (total = 40 accelerated IR-TMS treatments) in an open-label clinical trial with an adaptive treatment design-if one target site region demonstrates superior treatment responses, the remaining participant sample will undergo IR-TMS treatments on that target site.

Connect with a study center

  • Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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