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Ultrasound Therapy

LIFU for Cocaine Use Disorder

N/A

Recruiting

Led By Nassima Ait-Daoud Tiouririne, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will test if Low-Intensity Focused Ultrasound (LIFU) can reduce cravings for cocaine. 60 people with Cocaine Use Disorder (CUD) will be screened and 30 will be enrolled to see the effects of LIFU on craving.

Who is the study for?

This trial is for adults over 18 with a recent diagnosis of cocaine use disorder, who can lie still for imaging tests, have reliable transport, and stable housing. They must be able to avoid cocaine at certain times during the study and meet criteria for MRI scans.Check my eligibility

What is being tested?

The study is testing Low-Intensity Focused Ultrasound (LIFU) against a sham device to see if it reduces cravings in people with Cocaine Use Disorder by looking at brain activity and subjective craving levels after exposure to cocaine cues.See study design

What are the potential side effects?

Since this trial involves non-invasive ultrasound technology, side effects are expected to be minimal. However, participants may experience discomfort or mild headaches from lying down during the procedure or from the sham device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

No evidence of neurological or other adverse events related to LIFU

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-Intensity Focused Ultrasound (LIFU)Experimental Treatment1 Intervention

All subjects to receive LIFU and Sham in a randomized order.

Group II: Sham LIFUPlacebo Group1 Intervention

All subjects to receive LIFU and Sham in a randomized order.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-Intensity Focused Ultrasound

2020

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,043 Total Patients Enrolled

Nassima Ait-Daoud Tiouririne, MDPrincipal InvestigatorUniversity of Virginia, Center for Leading Edge Addiction Research

1 Previous Clinical Trials

294 Total Patients Enrolled

Media Library

Low-Intensity Focused Ultrasound (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05857852 — N/A

Cocaine Dependence Research Study Groups: Low-Intensity Focused Ultrasound (LIFU), Sham LIFU

Cocaine Dependence Clinical Trial 2023: Low-Intensity Focused Ultrasound Highlights & Side Effects. Trial Name: NCT05857852 — N/A

Low-Intensity Focused Ultrasound (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857852 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still enrolling participants?

"Clinicaltrials.gov reveals that recruitment for this research endeavour is in progress, which was first offered on March 1st 2023 and underwent a recent update on May 4th 2023."

Answered by AI

How many participants are partaking in this medical study?

"Affirmative. Based on the information published on clinicaltrials.gov, this study is actively seeking out participants and was recently updated on May 4th 2023- it started recruiting from March 1st of that year. The trial desires 30 patients to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Nassima Ait-Daoud Tiouririne 2023. "Low-Intensity Focused Ultrasound for Cocaine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05857852.