CompletedNot Applicable

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

United States25 participantsStarted 2023-03-24

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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks.

Timeframe: 8 weeks

Trial details

NCT IDNCT05857852

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Cocaine Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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

Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks.

Timeframe: 8 weeks