Recruiting

Ultrasound Neuromodulation

Sponsor:

UCLA

Code:

NCT06518785

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Intensity Focused Ultrasound

Study Details

Brief summary:

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

Conditions

Alcohol Use Disorder

Study ID

NCT06518785

Start date

Jan 7, 2025

Status verified date

Aug, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Low Intensity Focused Ultrasound

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

Primary outcome measure

  • Incidence of LIFU-related adverse events. [ Time Frame: Through study completion, an average of 5 weeks ]
  • Reward network activity in response to alcohol cues. [ Time Frame: 3 visits over 3 weeks ]

Central Contacts and Locations

Central contacts

Catherine Borror, BS, CCRP

415-514-6551TN2Lab@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Catherine Borror, BS, CCRP

415-514-6551TN2Lab@ucsf.edu

Principal Investigator:

Khaled Moussawi, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Keywords

  • Substance Use Disorder
  • Low-Intensity Focused Ultrasound
  • Transcranial Focused Ultrasound
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-09-04.