RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-02-03
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06648642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. PEth \>20 ng/mL (at baseline)
  3. 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. 4. Able to attend all study appointments
  5. 5. Fluent in English
  1. 1. Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
  2. 2. Inability to provide informed consent
  3. 3. Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
  4. 4. Currently enrolled in AUD treatment
  5. 5. Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
  6. 6. Any history or signs of serious medical or neurological illness including seizure disorders
  7. 7. History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
  8. 8. Liver enzymes that are more than 5x the normal range
  9. 9. Females will be excluded if they are pregnant
  10. 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.)

Contacts and Locations

Study Contact

Brett C Ginsburg, PhD
CONTACT
210-567-0871
ginsburg@uthscsa.edu
Tara Wright, PhD, MS
CONTACT
210-450-3903
wrightt3@uthscsa.edu

Principal Investigator

Brett C Ginsburg, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Brett C Ginsburg, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Transcranial magnetic stimulation
  • TMS
  • Phosphatidylethanol

Additional Relevant MeSH Terms

  • Alcohol Use Disorder