Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Alcohol Use Disorder

Treatments: Device: Low Intensity Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06518785

24-41883

Details and patient eligibility

About

This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.

Full 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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

VS LIFU/ VPL LIFU

Experimental group

Description:

Participants will be assigned to receive VS LIFU during the first LIFU treatment session.

Treatment:

Device: Low Intensity Focused Ultrasound

VPL LIFU/VS LIFU

Active Comparator group

Description:

Participants will be assigned to receive VPL LIFU during the first LIFU treatment session.

Treatment:

Device: Low Intensity Focused Ultrasound