Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Study Overview
=================
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.

Official Title
-----------------
Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Conditions
-----------------
Ultrasound, Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse

Intervention / Treatment
-----------------
* Device: Low-Intensity Focused Ultrasound
* Device: Sham LIFU device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Decrease in average craving score by 25% for LIFU compared to sham | Participant, subjective rating of cocaine-related craving | 8 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance Use Disorders, Chemically-Induced Disorders, Substance-related disorders, Cocaine Addiction, Cocaine