Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Drinking Behavior, Drinking Problem

In brief

Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.

Key facts

Study ID

NCT06415721

Run by

VA Palo Alto Health Care System

People needed

40

Starts

2025-08-25

Expected to finish

2026-01-01

Last updated by the study team

2025-08-13

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between age 25 and 75.
• Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
• Able to attend scheduled clinic visits
• Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
• If on a medication regimen, that regimen will be stable for the duration of the study;
• Fluency in English.

You may not qualify if…

• Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
• General medical condition, disease or neurological disorder that interferes with the assessments or participation.
• Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
• Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
• Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
• Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
• Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
• unstable chronic illness.
• Current or lifetime history of bipolar disorder or psychosis.
• Participation in another concurrent intervention based clinical trial.

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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