Alcohol Use Disorder
Conditions
Keywords
Transcranial magnetic stimulation, TMS, Phosphatidylethanol
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.
Detailed 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 treatment design-if one target site region demonstrates superior treatment responses, the remaining participant sample will undergo IR-TMS treatments on that target site.
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
Sponsors
The University of Texas Health Science Center at San Antonio
Wellcome Leap Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A 3-arm open label, adaptive randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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. 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Phosphatidylethanol (PEth) level | 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
| Measure | Time frame | Description |
|---|---|---|
| Brain functional connectivity | Baseline to 6 months | Unified Structural Equation Modeling (SEM) analyses will be used for image analysis. |
Countries
United States
Contacts
CONTACTBrett C Ginsburg, PhD
CONTACTTara Wright, PhD, MS
PRINCIPAL_INVESTIGATORBrett C Ginsburg, PhD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed