Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Not Applicable

Recruiting

• Conditions: Ultrasound; Cocaine Dependence; Cocaine Abuse; Cocaine Use Disorder
• Interventions: Device: Sham LIFU device; Device: Low-Intensity Focused Ultrasound

• Registration Number: NCT05857852
• Lead Sponsor: University of Virginia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham LIFU	Sham LIFU device	All subjects to receive LIFU and Sham in a randomized order.
Low-Intensity Focused Ultrasound (LIFU)	Low-Intensity Focused Ultrasound	All subjects to receive LIFU and Sham in a randomized order.

Primary Outcome Measures

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

Trial Locations

Locations (1)

UVA Center for Leading Edge Addiction Research; 🇺🇸 Charlottesville, Virginia, United States