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NCT Number: NCT06518785

Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Andrew Kayser, MD, PhD

SUB_INVESTIGATOR

Catherine Borror, BS, CCRP

CONTACT

[email protected]

415-514-6551

Khaled Moussawi, MD, PhD

PRINCIPAL_INVESTIGATOR

Sierra Brandts, BS

CONTACT

[email protected]

415-514-6551

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Low Intensity Focused Ultrasound

Device

An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.

Other names: LIFU

Primary outcomes

  1. Incidence of LIFU-related adverse events.

    Time frame: Through study completion, an average of 5 weeks

    This will be assessed through monitoring for adverse events (AE) throughout the study.

  2. Reward network activity in response to alcohol cues.

    Time frame: 3 visits over 3 weeks

    Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Borror, BS, CCRP

CONTACT

[email protected]

415-514-6551

Sierra Brandts, BS

CONTACT

[email protected]

415-514-6551

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 24, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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