UnknownNot Applicable

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

United States30 participantsStarted 2023-03-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure

Timeframe: 8 weeks

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

Timeframe: 8 weeks

No evidence of neurological or other adverse events related to LIFU

Timeframe: 8 weeks

Trial details

NCT IDNCT05857852

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

Tamika Braveheart, MA

434-243-0568 ats3z@uvahealth.org

View on ClinicalTrials.gov More Cocaine Use Disorder trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.