Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Cocaine Dependence Clinical Trial

Official title:

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857852
• Other study ID #: HSR220247
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: University of Virginia
• Contact: Tamika Braveheart, MA
• Phone: 434-243-0568
• Email: ats3z[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine Dependence
• Cocaine Use Disorder
• Cocaine-Related Disorders
• Disease
• Ultrasound

Intervention

Device:
• Low-Intensity Focused Ultrasound
Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions
• Sham LIFU device
Sham LIFU device administered in one of two sessions

Locations

Country	Name	City	State
United States	UVA Center for Leading Edge Addiction Research	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure	Evidence on MRI of BOLD activity in the dAI region	8 weeks
Primary	Decrease in average craving score by 25% for LIFU compared to sham	Participant, subjective rating of cocaine-related craving	8 weeks
Primary	No evidence of neurological or other adverse events related to LIFU	MRI images will show congruity of brain data over course of study	8 weeks