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New treatment option for Alcohol Use Disorder
Official title Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)
ClinicalTrials.gov ID: NCT06648642
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Two self-reported heavy drinking episodes (\>4 drinks for men, \>3 for women) or \>13 drinks in the last 14 days (at screening)
- PEth \>20 ng/mL (at baseline)
- Diagnosis of a current, moderate to severe AUD assessed by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)...
- Able to attend all study appointments
- Fluent in English
You likely can't join if
- Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
- Inability to provide informed consent
- Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
- Currently enrolled in AUD treatment
- Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective...
- Any history or signs of serious medical or neurological illness including seizure disorders
See the full eligibility criteria
- Two self-reported heavy drinking episodes (\>4 drinks for men, \>3 for women) or \>13 drinks in the last 14 days (at screening)
- PEth \>20 ng/mL (at baseline)
- 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
- Able to attend all study appointments
- Fluent in English
- Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
- Inability to provide informed consent
- Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
- Currently enrolled in AUD treatment
- Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
- Any history or signs of serious medical or neurological illness including seizure disorders
- History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
- Liver enzymes that are more than 5x the normal range
- Females will be excluded if they are pregnant
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.