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Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness

2026年7月30日 更新者：National Taiwan University Hospital

The goal of this clinical trial is to investigate the safety and efficacy of applying low-intensity focused ultrasound targeting the nucleus accumbens in individuals with opioid or amphetamine use disorders. The main questions it aims to answer is:

- Low-intensity focused ultrasound targeting the nucleus accumbens demonstrates sufficient safety and predictable therapeutic efficacy in individuals with opioid or amphetamine use disorders.

Participants will:

  • Received Low-intensity focused ultrasound neuromodulation once
  • Visit the clinic for checkups and asessment at 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, 1.5 years, and 2 years after received Low-intensity focused ultrasound neuromodulation.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 台湾
      • Taipei、台湾、100229
        • 招聘中
        • National Taiwan University Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Meets the DSM-5 criteria for opioid use disorder or amphetamine use disorder, with a severity level of severe, and does not currently meet the criteria for in sustained remission;
  • Within 7 days prior to the screening assessment, the participant must have been receiving a stable dose of medication treatment, such as methadone, buprenorphine/naloxone, or naltrexone;
  • Within 7 days prior to the screening assessment, the participant must have abstained from illicit substances and alcohol, and must have a negative urine drug test;
  • The bilateral nucleus accumbens must be clearly identifiable on magnetic resonance imaging (MRI), such that they are sufficient for treatment targeting and for indirect measurement from other anatomical structures;
  • The participant must be able to communicate effectively and express their feelings and experiences during the study procedures;
  • The participant must be willing to comply with the study requirements, including adherence to prescribed medications and cooperation with study visits and assessments.

(The participant must have the capacity to make independent medical decisions, as determined by the clinical team.)

Exclusion Criteria:

  • Presence of neurological disorders or major psychiatric disorders, such as acute-phase schizophrenia spectrum disorder, acute-phase bipolar disorder, acute-phase major depressive disorder, severe cognitive impairment, or recent suicidal ideation or plan;
  • Antisocial personality disorder;
  • Occurrence of major physical health problems within 6 months prior to the trial, including: Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmia, tachycardia or bradycardia (>100 bpm or <60 bpm), abnormal systolic blood pressure (>180 mmHg or <90 mmHg), or abnormal diastolic blood pressure (>180 mmHg); Platelet or coagulation abnormalities (INR > 1.5) or current use of medications that may cause anticoagulation, such as warfarin or Avastin; Renal dysfunction (eGFR < 30 mL/min/1.73 m²) or ongoing hemodialysis; Severe infection; Immunocompromised status; History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within the past 6 months, or brain tumor; Neurological diseases, such as stroke, epilepsy, Parkinson's disease, dementia, or related disorders; Any other physical illness that, based on clinical evaluation, may pose a significant risk to physical function or life during treatment.
  • Participants who, upon evaluation, are deemed unsuitable for MR-guided focused ultrasound treatment, including those with a low skull density ratio (<0.4), intracranial implants, or energy-absorbing structures or sensitive tissues along the ultrasound beam path that cannot be avoided (such as prior ventriculoperitoneal shunt sites, surgical metal clips, significant calcifications, extensive scarring, or any rigid implants). During the pre-treatment evaluation, a head CT scan will be performed to determine whether the skull density ratio is suitable for focused ultrasound treatment. Based on prior theoretical evidence, an excessively low skull density ratio may reduce the efficiency of MR-guided focused ultrasound and increase the risk of adverse effects, and therefore such participants are considered unsuitable for focused ultrasound treatment.
  • Structural abnormality of either side of the nucleus accumbens;
  • Contraindications to MRI, such as claustrophobia, allergy to MRI contrast agents, or the presence of metallic implants incompatible with MRI;
  • Contraindications to PET imaging, such as allergy to radiopharmaceutical contrast agents;
  • Inability to comply with trial-related instructions, lack of legal/behavioral capacity, or lack of motivation to receive treatment;
  • Pregnancy or breastfeeding;
  • Scalp atrophy or poor wound healing of the scalp;
  • Any other condition that, in the physician's judgment, makes the participant unsuitable for enrollment in the clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：实验组
设备：Low-intensity focused ultrasound
transcranially deliver focal energy into the accumbens nucleus in the brain
假比较器：控制组
设备：false stimulus
false stimulus

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Substance craving intensity
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Urinalysis
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Whether urine screening tests are positive for opioids and amphetamines. The intervention will be considered effective if the positivity rate decreases by 50% one month after the intervention compared with the time of intervention.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Severity of Dependence
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Stimulant Relapse Risk
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment

次要结果测量

结果测量
措施说明
大体时间
Mental health state
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Patient Health Questionnaire (PHQ-9) to measure participants' mental health state, greater scores of these scales shows worse mental health state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Executive function assessment
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Behavior Rating Inventory of Executive Function (BRIEF) to assess how well executive function of participants is.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Neuropsychological function assessment
大体时间：Before intervention, three months, six months, a year, two year after treatment
Using Cambridge Gambling Task (CGT) to assess Neuropsychological function since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Before intervention, three months, six months, a year, two year after treatment
functional Magnetic Resonance Imaging
大体时间：Before intervention, 24hours, a month, three months after treatment
Because the nucleus accumbens, the intervention target, may be involved in craving, functional magnetic resonance imaging (fMRI) will be used to assess changes in brain activation during the craving task before and after treatment.
Before intervention, 24hours, a month, three months after treatment
Positron Emission Tomography
大体时间：Before intervention, a month after treatment
Because neuromodulation may affect metabolic activity in the nucleus accumbens, positron emission tomography (PET) will be used to measure cerebral metabolism and compare changes before and after the intervention.
Before intervention, a month after treatment
Anxiety state
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Hamilton Anxiety Rating Scale (HAM-A), and Generalized Anxiety Disorder questionnaire(GAD-7) to measure participants' anxiety state, greater scores of these scales shows worse anxiety state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Depression state
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Hamilton Depression Rating Scale (HAM-D), to measure participants' mental health state, greater scores of these scales shows worse depression state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Attendtion state
大体时间：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Adult ADHD Self-Report Scale (ASRS) to assess how well attention state of participants is.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Working memory capacity
大体时间：Before intervention, three months, six months, a year, two year after treatment
Using N-back test to assess working memory capacity since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Before intervention, three months, six months, a year, two year after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Taiwan University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月1日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年3月12日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 202404026DINC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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