NCT05857852

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 4, 2023

Last Update Submit

May 4, 2023

Conditions

Cocaine Use DisorderCocaine DependenceCocaine AbuseUltrasound

Keywords

Substance Use DisordersChemically-Induced DisordersSubstance-related disordersCocaine AddictionCocaine

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Low-Intensity Focused Ultrasound (LIFU)

EXPERIMENTAL

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

Device: Low-Intensity Focused Ultrasound

Sham LIFU

SHAM COMPARATOR

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

Device: Sham LIFU device

Interventions

Low-Intensity Focused UltrasoundDEVICE

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

Low-Intensity Focused Ultrasound (LIFU)
Sham LIFU deviceDEVICE

Sham LIFU device administered in one of two sessions

Sham LIFU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Please contact PI or Study Coordinator for more details.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Nassima Ait-Daoud Tiouririne, MD

    University of Virginia, Center for Leading Edge Addiction Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamika Braveheart, MA

CONTACT

434-243-0568ats3z@uvahealth.org

Tracie Kostelac

CONTACT

434-243-0563TLK5D@uvahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Single-blind study
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and NB Sciences

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)