此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Repetitive Transcranial Magnetic Stimulation for People With Etomidate Addiction (SToP-E-rTMS x Etomidate) (SToP-E)

2026年7月26日 更新者：The University of Hong Kong

Substance Misuse To Psychiatric Disorders for Etomidate -Repetitive Transcranial Magnetic Stimulation for People With Etomidate Addiction: a 6-month, Double-blind, Randomized, Sham-controlled Trial

The goal of this clinical trial is to learn if high-frequency rTMS works to treat etomidate addiction in adults. It will also learn about the safety and tolerability of rTMS. The main questions it aims to answer are:

  • Does active rTMS reduce craving, amount of etomidate use, frequency of etomidate use, and severity of etomidate use disorder?
  • Does active rTMS improve cognitive biases related to delayed reward discounting and risk sensitivity?
  • What side-effects do participants have when receiving rTMS?

Researchers will compare active rTMS to sham rTMS to see if active rTMS works to treat etomidate addiction.

Participants will:

  • Receive active rTMS or sham rTMS over 4 weeks
  • Complete 20 rTMS sessions in total
  • Visit the clinic for treatment sessions and follow-up assessments
  • Complete assessments of etomidate use, craving, withdrawal symptoms, mood symptoms, cognition, and decision-making

Attend follow-up assessments up to 6 months after baseline

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a 6-month, double-blind, randomized, sham-controlled pilot clinical trial evaluating high-frequency repetitive transcranial magnetic stimulation (rTMS) for people with etomidate addiction. Etomidate misuse has become an emerging public health concern, but there is currently no established treatment specifically for etomidate addiction. This study will examine whether active rTMS delivered to the left dorsolateral prefrontal cortex can reduce etomidate craving, use, and dependence severity compared with sham rTMS.

The study will enroll 40 participants with etomidate use disorder. Participants will be randomly assigned in a 1:1 ratio to receive either active rTMS or sham rTMS. Both participants and outcome assessors will be blinded to treatment allocation. The intervention consists of 20 rTMS sessions delivered over 4 weeks, followed by an observation maintenance phase with follow-up assessments up to 6 months from baseline.

The study will assess changes in etomidate use, craving, withdrawal symptoms, dependence severity, anxiety, depression, global cognition, psychomotor speed, and cognitive biases related to delayed reward discounting and risk sensitivity. These assessments will help determine whether rTMS may be a feasible and potentially effective intervention for etomidate addiction and related decision-making processes.

研究类型

介入性

注册 (估计的)

40

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

  • 姓名：Albert KK Chung
  • 电话号码：+85260440993
  • 邮箱：Chungkka@hku.hk

学习地点

  • 香港
    • Hong Kong
      • Hong Kong、Hong Kong、香港、000000

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:

  • Able to read and communicate in English and/or Chinese
  • Able to give informed consent and/or able to provide an informed consent from the legal guardian (if applicable)
  • Using etomidate and/or its related analogues as the primary psychoactive substance of abuse

  • Suffering from etomidate addiction as defined by:

    1. Etomidate Use Disorder classified under "Sedative-, Hypnotic-, or Anxiolytic Use Disorder" according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) with severity ≥ 1, or
    2. Harmful Use or Dependence for etomidate classified under "Mental and behavioral disorders due to use of sedatives or hypnotics" according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), or
    3. Hazardous use, harmful use or dependence classified under "Hazardous use of sedatives, hypnotics or anxiolytics" or "Disorders due to use of sedatives, hypnotics or anxiolytics" according to the Clinical descriptions and diagnostic requirements for International Classification of Diseases 11th Revision (ICD-11) mental, behavioral, and neurodevelopmental disorders.

Exclusion Criteria:

  • Age < 18 years old
  • Unable to read English or Chinese
  • Unable to give informed consent

  • Had been diagnosed with the following disorders including:

    1. Neurodevelopmental Disorders:

  • DSM-5: Intellectual Disabilities, Communication Disorders, Specific Learning Disorder, Autism Spectrum Disorder and Motor Disorders
  • International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11): Disorders of intellectual development (6A00), Developmental speech or language disorders (6A01), Autism spectrum disorder (6A02), Developmental learning disorder (6A03), Developmental motor coordination disorder (6A04), Stereotyped movement disorder (6A06), Primary tics or tic disorders (8A05.0)
  • Other DSM-5 defined Substance Use Disorder greater than moderate in severity (i.e., severity score ≥4)
  • Neurocognitive Disorders (DSM-5, or ICD-11 6D70-72 & 6D80-86) 2. Contra-indicated to undergo rTMS:
  • with electronic and/or magnetic implants (e.g., pacemaker, implantable cardioverter defibrillator [ICD], cerebral shunts, cochlear implant, etc.)
  • with metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)
  • pregnant
  • with any known or history of neurological conditions including cerebral vascular accidents (CVA), epilepsy, brain tumor or space occupying lesion, etc.
  • poorly controlled or unstable diabetes mellitus
  • receiving unstable dose(s) of antipsychotics, antidepressants, benzodiazepines and/or anticonvulsants in the past 3 months

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Active rTMS
Subjects receive 20 high-frequency rTMS sessions over 4 weeks.
设备：high-frequency Repetitive Transcranial Magnetic Stimulation
high-frequency rTMS using Magventure TMS system using the Coil Cool-B70 Active/Placebo Bended Butterfly coil is delivered at the dorsolateral prefrontal cortex of consented subjects
假比较器：Sham rTMS
Subjects receive 20 Sham rTMS sessions over 4 weeks.
设备：Repetitive transcranial magnetic stimulation
Sham rTMS will be delivered using the Coil Cool-B70 Active/Placebo Bended Butterfly coil, which generates a negligible magnetic field. The sham procedure will follow the same schedule as the active rTMS arm.

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
Change in etomidate craving
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in craving measured by the Craving Automated Scale-Substance from baseline to follow-up. Higher scores indicate stronger craving.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in etomidate withdrawal symptoms
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in withdrawal symptoms measured by the Clinical Institute Withdrawal Assessment for Benzodiazepines from baseline to follow-up.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in amount of etomidate use
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in the amount of etomidate use over the past 30 days measured by the Beat Drugs Fund Evaluation Question Set No. 5 and substance use interview from baseline to follow-up.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in frequency of etomidate use
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in the frequency of etomidate use over the past 30 days measured by the Beat Drugs Fund Evaluation Question Set No. 5 and substance use interview from baseline to follow-up.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in severity of dependence
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in severity of dependence measured by the Severity of Dependence Scale from baseline to follow-up. Higher scores indicate greater dependence severity.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in urine-confirmed etomidate use
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in etomidate use status assessed by urine test from baseline to follow-up. Urine testing will be used to assess recent etomidate use and compare biological testing results with self-reported etomidate use.
Baseline, Week 1, Week 4, Month 3, and Month 6

次要结果测量

结果测量
措施说明
大体时间
Change in anxiety symptoms
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in anxiety symptoms measured by the Beck Anxiety Inventory from baseline to follow-up. Higher scores indicate more severe anxiety symptoms.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in depressive symptoms
大体时间：Baseline, Week 1, Week 4, Month 3, and Month 6
Change in depressive symptoms measured by the Beck Depression Inventory-II from baseline to follow-up. Higher scores indicate more severe depressive symptoms.
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in delayed reward discounting
大体时间：Baseline, Week 4, Month 3, and Month 6
Change in delayed reward discounting measured by a delay discounting task from baseline to follow-up. The task assesses preference for smaller immediate rewards versus larger delayed rewards.
Baseline, Week 4, Month 3, and Month 6
Change in risk sensitivity
大体时间：Baseline, Week 4, Month 3, and Month 6
Change in risk sensitivity measured by a risk preference task from baseline to follow-up. The task assesses preference for smaller safe rewards versus larger risky rewards.
Baseline, Week 4, Month 3, and Month 6
Change in global cognitive function
大体时间：Baseline, Week 4, Month 3, and Month 6
Change in global cognitive function measured by the Montreal Cognitive Assessment-Hong Kong Chinese version or English version from baseline to follow-up. Higher scores indicate better global cognitive function.
Baseline, Week 4, Month 3, and Month 6
Change in psychomotor speed
大体时间：Baseline, Week 4, Month 3, and Month 6
Change in psychomotor speed measured by the Digit Symbol Substitution Test from baseline to follow-up. Higher scores indicate better psychomotor speed.
Baseline, Week 4, Month 3, and Month 6

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

The University of Hong Kong

调查人员

  • 首席研究员：Albert KK Chung、Department of Psychiatry, The University of Hong Kong

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 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月31日

研究完成 (估计的)

2029年3月31日

研究注册日期

首次提交

2026年7月26日

首先提交符合 QC 标准的

2026年7月26日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月26日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UW 26-263

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

This is because of the potential legal consequences to the participants as etomidate abuse in the study locality is considered criminal.

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.

订阅