Low-Intensity Focused Ultrasound for Cocaine Use Disorder

University of Virginia25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Cocaine Use Disorder

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Decrease in average craving score by 25% for LIFU compared to sham

Participant, subjective rating of cocaine-related craving

Time frame: 8 weeks

Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks.

Immediately after each LIFU or sham session, participants underwent a LIFU adverse event checklist, MoCA™, and focused neurological examination. Participants also completed a 24-hour follow-up safety assessment and a 4-week post-Visit 2 repeat assessment.

Time frame: 8 weeks

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes