Low-Intensity Focused Ultrasound for Cocaine Use Disorder

University of Virginia

Status: Enrolling

Conditions: Cocaine Dependence; Cocaine Abuse; Cocaine Use Disorder; Ultrasound

Treatments: Device: Low-Intensity Focused Ultrasound; Device: Sham LIFU device

Study type: Interventional

Funder types: Other

Identifiers

NCT05857852

HSR220247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Low-Intensity Focused Ultrasound (LIFU)

Experimental group

Description:

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

Treatment:

Device: Low-Intensity Focused Ultrasound

Sham LIFU

Sham Comparator group

Description:

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

Treatment:

Device: Sham LIFU device