Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
Purpose
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
Condition
- Alcohol Use Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Due to the objectives of the study, the identity of LIFU treatments will not be known to research staff performing the data analysis or participants.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VS LIFU/ VPL LIFU |
Participants will be assigned to receive VS LIFU during the first LIFU treatment session. |
|
|
Active Comparator VPL LIFU/VS LIFU |
Participants will be assigned to receive VPL LIFU during the first LIFU treatment session. |
|
Recruiting Locations
University of California, San Francisco
San Francisco, California 94143
San Francisco, California 94143
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
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).