NCT07010016进行中（未招募）不适用
Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.
详细描述
This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 diagnostic criteria for OUD and/or other SUDs with at least a 2-year history.
- •Currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction
- •Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; or receiving outpatient/inpatient/residential treatment from similar SUD treatment programs.
- •Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
- •Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
排除标准
- •Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
- •History of any clinically significant neurological disorder.
- •History of stroke or brain lesion with observable structural abnormalities in the targeted brain region.
- •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.
- •An abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings).
- •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.
- •Past or present diagnosis of schizophrenia or psychotic disorder (assessed via SCID-
- •History of medically verified suicide attempt within the past year.
- •Meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD).
- •Current substance use treatment mandated by court of law.
- •Subject who is currently participating in another clinical investigation with an active
- •treatment arm.
- •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
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: Beginning Day 0 (the day of the FUS procedure) through Week 4
Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs
次要结局
未报告次要终点
研究者
Manish Ranjan
Asst Prof RNI
West Virginia University
研究点 (2)
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