Status:
RECRUITING
Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
Lead Sponsor:
University of California, San Francisco
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wi...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age.
- 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.
- Be willing to undergo a brain MRI and follow study protocol.
Exclusion
- Pregnant or breastfeeding.
- Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.
- Non-English speaking.
- Other investigational AUD treatments.
- Primary psychosis, Bipolar I, or severe personality disorder.
- Active suicidality or history of suicide attempt in the past 5 years.
- Cognitive impairment (MoCA \<24)
- Significant medical or neurological disease, or life expectancy \<12 mos.
- Significant brain abnormality on brain imaging.
- Any MRI exclusion criteria.
Key Trial Info
Start Date :
January 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06518785
Start Date
January 7 2025
End Date
September 1 2030
Last Update
September 4 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143