A Randomized, Sham-Controlled Trial Investigating Low Intensity Focused Ultrasound as a Novel Treatment for Refractory Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ali Rezai
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.
详细描述
The overall objective of this study is to assess the safety, tolerability, and feasibility of using Low Intensity Focused Ultrasound (LIFU) to treat opioid use disorder (OUD) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization will occur after all inclusion criteria have been met at which time participants will be randomized 1:1 to either the Active or the Sham arm.This study will be performed in a double-blind manner, with participants as well as investigators and study staff involved with assessments unaware of treatment assignment.
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 22 - 60 years at time of enrollment.
- •Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history.
- •Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.
排除标准
- •Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours.
- •History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
- •History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC).
- •Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS).
- •Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
- •More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
- •Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
- •Subject with impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
- •Hepatic function laboratory values which are > 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator.
- •Past or present diagnosis of schizophrenia or psychotic disorder.
- •Subject unwilling to attempt abstinence from illicit substance use during the course of the study.
- •Unable to speak, read and understand English.
- •Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
研究组 & 干预措施
LIFU Treatment
干预措施: Low Intensity Focussed Ultrasound (Device)
Sham treatment
干预措施: Low Intensity Focussed Ultrasound (Device)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: Post-ExAblate Procedure through 90 day Follow-Up
Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurrence.
Changes in Opioid Use
时间窗: Post-ExAblate Procedure through 90 day Follow-Up
Changes in opioid use will be measured using quantitative urine toxicology via liquid chromatography/mass spectrometry (LC/MS).
次要结局
未报告次要终点