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NCT06518785NARecruiting

Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

University of California, San Francisco

Start Date

1/7/2025

Completion Date

9/1/2030

Summary

This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.

Detailed Description

This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period. 3. Be willing to undergo a brain MRI and follow study protocol. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data. 3. Non-English speaking. 4. Other investigational AUD treatments. 5. Primary psychosis, Bipolar I, or severe personality disorder. 6. Active suicidality or history of suicide attempt in the past 5 years. 7. Cognitive impairment (MoCA \<24) 8. Significant medical or neurological disease, or life expectancy \<12 mos. 9. Significant brain abnormality on brain imaging. 10. Any MRI exclusion criteria.

Interventions

DEVICE

Low Intensity Focused Ultrasound

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Conditions

Alcohol Use Disorder

Locations

University of California, San Francisco

San Francisco, California 94143

United States