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Low-Intensity Focused Ultrasound for Cocaine Use Disorder

NCT05857852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-15

No results posted yet for this study

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.

Conditions

  • Cocaine Use Disorder
  • Cocaine Dependence
  • Cocaine Abuse
  • Ultrasound

Interventions

DEVICE

Low-Intensity Focused Ultrasound

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

DEVICE

Sham LIFU device

Sham LIFU device administered in one of two sessions

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Nassima Ait-Daoud Tiouririne, MD · University of Virginia, Center for Leading Edge Addiction Research

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-03-01
Completion
2025-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857852 on ClinicalTrials.gov