Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT06518785
• Lead Sponsor: University of California, San Francisco

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 with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2025-01-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2030-09
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reward network activity in response to alcohol cues.	3 visits over 3 weeks	Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI.
Incidence of LIFU-related adverse events.	Through study completion, an average of 5 weeks	This will be assessed through monitoring for adverse events (AE) throughout the study.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States