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NCT Number: NCT06648642

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Brett C Ginsburg, PhD

CONTACT

[email protected]

210-567-0871

Tara Wright, PhD, MS

CONTACT

[email protected]

210-450-3909

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.)

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

TMS applies a strong (~2 Tesla), rapidly changing electro-magnetic field at the scalp to induce electrical current flow in underlying brain tissues

Other names: Image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS)

Primary outcomes

  1. Measure of Phosphatidylethanol (PEth) level

    Time frame: Baseline, 1 month and 6 months

    Determine if accelerated IR-TMS significantly changes alcohol consumption (as measured by phosphatidylethanol (PEth)) in participants with AUD.

Secondary outcomes

  1. Brain functional connectivity

    Time frame: Baseline to 6 months

    Unified Structural Equation Modeling (SEM) analyses will be used for image analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Brett C Ginsburg, PhD

CONTACT

[email protected]

210-567-0871

Tara Wright, PhD, MS

CONTACT

[email protected]

210-450-3903

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Wellcome Leap Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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