Recruiting

IR-TMS

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06648642

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation (TMS)

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Study ID

NCT06648642

Start date

Feb 3, 2025

Status verified date

Feb, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Left dorsolateral prefrontal cortex (L-DLPFC) IR-TMS

Stimulation will be delivered to the L-DLPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.

active comparator: Dorsomedial prefrontal cortex (DMPFC) IR-TMS

Stimulation will be delivered to either the DMPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.

active comparator: Orbitofrontal cortex (OFC) IR-TMS

Stimulation will be delivered to either the OFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.

Interventions

Transcranial Magnetic Stimulation (TMS)

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

Primary outcome measure

  • Measure of Phosphatidylethanol (PEth) level [ Time Frame: Baseline, 1 month and 6 months ]

Central Contacts and Locations

Central contacts

Brett C Ginsburg, PhD

210-567-0871ginsburg@uthscsa.edu

Tara Wright, PhD, MS

210-450-3903wrightt3@uthscsa.edu

Locations

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Brett C Ginsburg, PhD

210-567-0871ginsburg@uthscsa.edu

Tara Wright, PhD, MS

210-450-3909WrightT3@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • Transcranial magnetic stimulation
  • TMS
  • Phosphatidylethanol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-02-05.