Clinical trial NCT05857852: Low-Intensity Focused Ultrasound for Cocaine Use Disorder
Official title: Low-Intensity Focused Ultrasound for Cocaine Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cocaine Use Disorder
Cocaine Dependence
Cocaine Abuse
Ultrasound
Keywords: Substance Use Disorders
Chemically-Induced Disorders
Substance-related disorders
Cocaine Addiction
Cocaine
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
timeFrame: 8 weeks
measure: Decrease in average craving score by 25% for LIFU compared to sham
timeFrame: 8 weeks
measure: No evidence of neurological or other adverse events related to LIFU
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Center for Leading Edge Addiction Research
state: Virginia
Study officials:
affiliation: University of Virginia, Center for Leading Edge Addiction Research
name: Nassima Ait-Daoud Tiouririne, MD
role: PRINCIPAL_INVESTIGATOR
References: