Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cocaine Use Disorder Cocaine Dependence Cocaine Abuse Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Single-blind study

Study Groups

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Low-Intensity Focused Ultrasound (LIFU)

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

Group Type EXPERIMENTAL

Low-Intensity Focused Ultrasound

Intervention Type DEVICE

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

Sham LIFU

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

Group Type SHAM_COMPARATOR

Sham LIFU device

Intervention Type DEVICE

Sham LIFU device administered in one of two sessions

Interventions

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Low-Intensity Focused Ultrasound

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

Intervention Type DEVICE

Sham LIFU device

Sham LIFU device administered in one of two sessions

Intervention Type DEVICE

Eligibility Criteria

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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)