Clinical trial NCT06648642: Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Transcranial magnetic stimulation
TMS
Phosphatidylethanol
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Wellcome Leap Inc.
First posted: 2024-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A 3-arm open label, adaptive randomized control trial
Primary purpose: TREATMENT

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.

Eligibility 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.)

Primary outcomes:
measure: Measure of Phosphatidylethanol (PEth) level
timeFrame: Baseline, 1 month and 6 months
Secondary outcomes:
measure: Brain functional connectivity
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Brett C Ginsburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: