RECRUITING

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Quick Facts

Study Start:2023-03-01
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05857852

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18 years and older with a history of cocaine use disorder
  2. * Have a current (past 6 months) DSM-5 diagnosis of cocaine use disorder (4 or more symptoms) assessed using the MINI neuropsychiatric interview
  3. * Have a blood alcohol content by breathalyzer, equal to 0.000 when informed consent document is signed
  4. * Ability to abstain from cocaine use at key points during study
  5. * Willingness and ability to comply with scheduled visits and study procedures
  6. * Ability to lie down for extended periods of time for imaging tests
  7. * Will have reliable transportation throughout study
  8. * Will have a stable residence during the 2 weeks prior to randomization and not be at risk of losing housing in next 2 months
  9. * Must meet criteria to have magnetic resonance imaging (MRI)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Tamika Braveheart, MA
CONTACT
434-243-0568
ats3z@uvahealth.org
Tracie Kostelac
CONTACT
434-243-0563
TLK5D@uvahealth.org

Principal Investigator

Nassima Ait-Daoud Tiouririne, MD
PRINCIPAL_INVESTIGATOR
University of Virginia, Center for Leading Edge Addiction Research

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Virginia

  • Nassima Ait-Daoud Tiouririne, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-03-01
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2025-03-01

Terms related to this study

Keywords Provided by Researchers

  • Substance Use Disorders
  • Chemically-Induced Disorders
  • Substance-related disorders
  • Cocaine Addiction
  • Cocaine

Additional Relevant MeSH Terms

  • Cocaine Use Disorder
  • Cocaine Dependence
  • Cocaine Abuse
  • Ultrasound