Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Sponsor

University of Virginia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05857852

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Use Disorder Cocaine Dependence Cocaine Abuse Ultrasound	Device: Low-Intensity Focused Ultrasound Device: Sham LIFU device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

At each of two intervention visits, participants will receive either LIFU or sham. At the completion of both visits, all participants will have received both, LIFU and sham.At each of two intervention visits, participants will receive either LIFU or sham. At the completion of both visits, all participants will have received both, LIFU and sham.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Single-blind study

Primary Purpose:

Health Services Research

Official Title:

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-Intensity Focused Ultrasound (LIFU) All subjects to receive LIFU and Sham in a randomized order.	Device: Low-Intensity Focused Ultrasound Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions
Sham Comparator: Sham LIFU All subjects to receive LIFU and Sham in a randomized order.	Device: Sham LIFU device Sham LIFU device administered in one of two sessions

Arm

Intervention/Treatment

Experimental: Low-Intensity Focused Ultrasound (LIFU)

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

Device: Low-Intensity Focused Ultrasound

Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions

Sham Comparator: Sham LIFU

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

Device: Sham LIFU device

Sham LIFU device administered in one of two sessions

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)