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Completed

NCT Number: NCT05857852

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

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.

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Key information

Conditions

Cocaine Use Disorder Chemically-Induced Disorders Cocaine Abuse Cocaine Dependence Cocaine-Related Disorders Mental Disorders Substance-Related Disorders Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Low-intensity focused ultrasound

Device

Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions

Sham LIFU device

Device

Sham LIFU device administered in one of two sessions

Primary outcomes

  1. 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

  2. Decrease in average craving score by 25% for LIFU compared to sham

    Time frame: 8 weeks

    Participant, subjective rating of cocaine-related craving

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
May 28, 2026

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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