NCT06415721 Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
| NCT ID | NCT06415721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Palo Alto Health Care System |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-25 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Daniel McCalley, PhD
PRINCIPAL INVESTIGATOR
Palo Alto VA Health Care System
Frequently Asked Questions
Who can join the NCT06415721 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06415721 currently recruiting?
Yes, NCT06415721 is actively recruiting participants. Contact the research team at mccalled@stanford.edu for enrollment information.
Where is the NCT06415721 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06415721 clinical trial?
NCT06415721 is sponsored by VA Palo Alto Health Care System. The principal investigator is Daniel McCalley, PhD at Palo Alto VA Health Care System. The trial plans to enroll 40 participants.