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
Conditions
Alcohol Use Disorder
Locations
University of California, San Francisco
San Francisco, California 94143
United States