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Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Primary Purpose

Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Intensity Focused Ultrasound
Sham LIFU device
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cocaine Use Disorder focused on measuring Substance Use Disorders, Chemically-Induced Disorders, Substance-related disorders, Cocaine Addiction, Cocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • UVA Center for Leading Edge Addiction ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low-Intensity Focused Ultrasound (LIFU)

Sham LIFU

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Decrease in average craving score by 25% for LIFU compared to sham
Participant, subjective rating of cocaine-related craving
No evidence of neurological or other adverse events related to LIFU
MRI images will show congruity of brain data over course of study

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05857852
Brief Title
Low-Intensity Focused Ultrasound for Cocaine Use Disorder
Official Title
Low-Intensity Focused Ultrasound for Cocaine Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse, Ultrasound
Keywords
Substance Use Disorders, Chemically-Induced Disorders, Substance-related disorders, Cocaine Addiction, Cocaine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Single-blind study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Intensity Focused Ultrasound (LIFU)
Arm Type
Experimental
Arm Description
All subjects to receive LIFU and Sham in a randomized order.
Arm Title
Sham LIFU
Arm Type
Sham Comparator
Arm Description
All subjects to receive LIFU and Sham in a randomized order.
Intervention Type
Device
Intervention Name(s)
Low-Intensity Focused Ultrasound
Intervention Description
Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions
Intervention Type
Device
Intervention Name(s)
Sham LIFU device
Intervention Description
Sham LIFU device administered in one of two sessions
Primary Outcome Measure Information:
Title
Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
Description
Evidence on MRI of BOLD activity in the dAI region
Time Frame
8 weeks
Title
Decrease in average craving score by 25% for LIFU compared to sham
Description
Participant, subjective rating of cocaine-related craving
Time Frame
8 weeks
Title
No evidence of neurological or other adverse events related to LIFU
Description
MRI images will show congruity of brain data over course of study
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamika Braveheart, MA
Phone
434-243-0568
Email
ats3z@uvahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tracie Kostelac
Phone
434-243-0563
Email
TLK5D@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud Tiouririne, MD
Organizational Affiliation
University of Virginia, Center for Leading Edge Addiction Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Center for Leading Edge Addiction Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamika Braveheart, MA, BSN
Phone
434-243-0568
Email
ats3z@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Tracie Kostelac
Phone
434-243-0563
Email
TLK5D@uvahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Low-Intensity Focused Ultrasound for Cocaine Use Disorder

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