Low-Intensity Focused Ultrasound for Cocaine Use Disorder

May 22, 2026 updated by: Nassima Ait-Daoud Tiouririne, University of Virginia
This study aims to understand the role of Low-Intensity Focused Ultrasound on craving levels for cocaine as evidenced by diagnostic imaging of the dorsal anterior insula (dAI) and subjective ratings. Data analysis will serve to show if 1) LIFU is safe and effective and to 2) examine the effects of LIFU on dAI BOLD activity and craving in response to cocaine cue-exposure. The study will screen 60 individuals with Cocaine Use Disorder (CUD) to arrive at 30 enrolled subjects, based on a 2:1 screen/randomization ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized single-blind, active, sham-controlled study.

This study will enroll thirty (30) individuals, aged 18 years and older, that meet the criteria for CUD. Participants will be recruited from the general population and will be asked to complete cognitive testing and measures, self-reported craving measures, and diagnostic exams including magnetic resonance imaging (MRI) and Computed Tomography (CT). Participants will also undergo functional MRI which entails being shown cocaine-related photos at regular intervals.

All participants will receive LIFU and sham interventions, but will be randomized to one of two sessions, and will return one month after the second session for an in-person follow-up. In total, there are five (5) in-person visits and two (2) phone calls to assess for adverse events, conducted over eight (8) weeks.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Center for Leading Edge Addiction Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18 years and older with a history of cocaine use disorder
  • Have a current (past 6 months) DSM-5 diagnosis of cocaine use disorder (4 or more symptoms) assessed using the MINI neuropsychiatric interview
  • Have a blood alcohol content by breathalyzer, equal to 0.000 when informed consent document is signed
  • Ability to abstain from cocaine use at key points during study
  • Willingness and ability to comply with scheduled visits and study procedures
  • Ability to lie down for extended periods of time for imaging tests
  • Will have reliable transportation throughout study
  • Will have a stable residence during the 2 weeks prior to randomization and not be at risk of losing housing in next 2 months
  • Must meet criteria to have magnetic resonance imaging (MRI)

Exclusion Criteria:

• Please contact PI or Study Coordinator for more details.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-Intensity Focused Ultrasound (LIFU)
All subjects to receive LIFU and Sham in a randomized order.
Device: Low-Intensity Focused Ultrasound
Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions
Sham Comparator: Sham LIFU
All subjects to receive LIFU and Sham in a randomized order.
Device: Sham LIFU device
Sham LIFU device administered in one of two sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
Time Frame: 8 weeks
Evidence on MRI of BOLD activity in the dAI region
8 weeks
Decrease in average craving score by 25% for LIFU compared to sham
Time Frame: 8 weeks
Participant, subjective rating of cocaine-related craving
8 weeks
Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks.
Time Frame: 8 weeks
Immediately after each LIFU or sham session, participants underwent a LIFU adverse event checklist, MoCA™, and focused neurological examination. Participants also completed a 24-hour follow-up safety assessment and a 4-week post-Visit 2 repeat assessment.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Nassima Ait-Daoud Tiouririne, MD, University of Virginia, Center for Leading Edge Addiction Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR220247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe