Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Device: Low Intensity Focused Ultrasound

• 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
• Status Verified: 2025-01
• Study Start: 2025-01-07
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2027-09
• Study Completion: 2027-09

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

Arm && Interventions

Group	Intervention	Description
VS LIFU/ VPL LIFU	Low Intensity Focused Ultrasound	Participants will be assigned to receive VS LIFU during the first LIFU treatment session.
VPL LIFU/VS LIFU	Low Intensity Focused Ultrasound	Participants will be assigned to receive VPL LIFU during the first LIFU treatment session.

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