New treatment using robot-guided magnetic stimulation for alcohol use disorder
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
This study is testing a new robot-guided treatment to help people with alcohol use disorder cut back on their drinking by targeting specific areas of the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06648642 on ClinicalTrials.gov |
What this trial studies
This study is testing a novel treatment called image-guided, robot navigated transcranial magnetic stimulation (IR-TMS) to help individuals with alcohol use disorder (AUD) reduce their drinking. Participants will be randomly assigned to one of three treatment groups, each targeting different areas of the brain based on personalized fMRI connectivity maps. The treatment involves multiple sessions of IR-TMS, along with brain scans and assessments of drinking behavior and mental health. The goal is to evaluate the effectiveness and durability of this innovative approach compared to traditional therapies.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate to severe alcohol use disorder who have experienced heavy drinking episodes.
Not a fit: Patients with other substance use disorders, severe psychiatric conditions, or those currently undergoing AUD treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for individuals struggling with alcohol use disorder.
How similar studies have performed: While this approach is innovative, similar studies using transcranial magnetic stimulation have shown promise in treating various conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
San Antonio, Texas
- Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Brett C Ginsburg, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Brett C Ginsburg, PhD
- Email: ginsburg@uthscsa.edu
- Phone: 210-567-0871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.