Low-Intensity Focused Ultrasound for Cocaine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Single-blind study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Please contact PI or Study Coordinator for more details.
研究组 & 干预措施
Low-Intensity Focused Ultrasound (LIFU)
All subjects to receive LIFU and Sham in a randomized order.
干预措施: Low-Intensity Focused Ultrasound (Device)
Sham LIFU
All subjects to receive LIFU and Sham in a randomized order.
干预措施: Sham LIFU device (Device)
结局指标
主要结局
Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
时间窗: 8 weeks
Evidence on MRI of BOLD activity in the dAI region
Decrease in average craving score by 25% for LIFU compared to sham
时间窗: 8 weeks
Participant, subjective rating of cocaine-related craving
No evidence of neurological or other adverse events related to LIFU
时间窗: 8 weeks
MRI images will show congruity of brain data over course of study
次要结局
未报告次要终点
研究者
Nassima Ait-Daoud Tiouririne
Professor of Psychiatry and NB Sciences
University of Virginia