Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

NCT06518785 | Recruiting FDA Device

• 1 other identifier: 24-41883
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of LIFU-related adverse events.

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

  Through study completion, an average of 5 weeks

• Reward network activity in response to alcohol cues.

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

  3 visits over 3 weeks

Study Arms (2)

VS LIFU/ VPL LIFU

EXPERIMENTAL

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

Device: Low Intensity Focused Ultrasound

VPL LIFU/VS LIFU

ACTIVE COMPARATOR

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

Device: Low Intensity Focused Ultrasound

Interventions

Low Intensity Focused Ultrasound DEVICE

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

Also known as: LIFU

VPL LIFU/VS LIFU; VS LIFU/ VPL LIFU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (5)

• Sarica C, Nankoo JF, Fomenko A, Grippe TC, Yamamoto K, Samuel N, Milano V, Vetkas A, Darmani G, Cizmeci MN, Lozano AM, Chen R. Human Studies of Transcranial Ultrasound neuromodulation: A systematic review of effectiveness and safety. Brain Stimul. 2022 May-Jun;15(3):737-746. doi: 10.1016/j.brs.2022.05.002. Epub 2022 May 6.

  PMID: 35533835 BACKGROUND

• Legon W, Adams S, Bansal P, Patel PD, Hobbs L, Ai L, Mueller JK, Meekins G, Gillick BT. A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Sci Rep. 2020 Mar 27;10(1):5573. doi: 10.1038/s41598-020-62265-8.

  PMID: 32221350 BACKGROUND

• Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.

  PMID: 34198105 BACKGROUND

• Mahoney JJ, Haut MW, Carpenter J, Ranjan M, Thompson-Lake DGY, Marton JL, Zheng W, Berry JH, Tirumalai P, Mears A, D'Haese P, Finomore VS, Hodder SL, Rezai AR. Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial. Front Psychiatry. 2023 Sep 15;14:1211566. doi: 10.3389/fpsyt.2023.1211566. eCollection 2023.

  PMID: 37779628 BACKGROUND

• Martin E, Aubry JF, Schafer M, Verhagen L, Treeby B, Pauly KB. ITRUSST consensus on standardised reporting for transcranial ultrasound stimulation. Brain Stimul. 2024 May-Jun;17(3):607-615. doi: 10.1016/j.brs.2024.04.013. Epub 2024 Apr 25.

  PMID: 38670224 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Khaled Moussawi, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Borror, BS, CCRP

CONTACT

415-514-6551; TN2Lab@ucsf.edu

Sierra Brandts, BS

CONTACT

415-514-6551; TN2Lab@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the objectives of the study, the identity of LIFU treatments will not be known to research staff performing the data analysis or participants.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)