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
The University of Texas Health Science Center at San Antonio
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.
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 t…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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. Alc…
Interventions
- DeviceTranscranial 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
Location
- Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral SciencesSan Antonio, Texas