Repetitive Transcranial Magnetic Stimulation for People With Etomidate Addiction (SToP-E-rTMS x Etomidate) (SToP-E)
26 de julio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Albert KK Chung
- Número de teléfono: +85260440993
- Correo electrónico: Chungkka@hku.hk
Ubicaciones de estudio
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 000000
- Queen Mary Hospital
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Contacto:
- Ablert KK Chung
- Correo electrónico: chungkka@hku.hk
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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:
- 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
- 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
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Active rTMS
Subjects receive 20 high-frequency rTMS sessions over 4 weeks.
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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
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Comparador falso: Sham rTMS
Subjects receive 20 Sham rTMS sessions over 4 weeks.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in etomidate craving
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in craving measured by the Craving Automated Scale-Substance from baseline to follow-up.
Higher scores indicate stronger craving.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in etomidate withdrawal symptoms
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in withdrawal symptoms measured by the Clinical Institute Withdrawal Assessment for Benzodiazepines from baseline to follow-up.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in amount of etomidate use
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in frequency of etomidate use
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in severity of dependence
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in severity of dependence measured by the Severity of Dependence Scale from baseline to follow-up.
Higher scores indicate greater dependence severity.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in urine-confirmed etomidate use
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in anxiety symptoms
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in anxiety symptoms measured by the Beck Anxiety Inventory from baseline to follow-up.
Higher scores indicate more severe anxiety symptoms.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in depressive symptoms
Periodo de tiempo: Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in depressive symptoms measured by the Beck Depression Inventory-II from baseline to follow-up.
Higher scores indicate more severe depressive symptoms.
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Baseline, Week 1, Week 4, Month 3, and Month 6
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Change in delayed reward discounting
Periodo de tiempo: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change in risk sensitivity
Periodo de tiempo: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change in global cognitive function
Periodo de tiempo: Baseline, Week 4, Month 3, and Month 6
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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.
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Baseline, Week 4, Month 3, and Month 6
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Change in psychomotor speed
Periodo de tiempo: Baseline, Week 4, Month 3, and Month 6
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Change in psychomotor speed measured by the Digit Symbol Substitution Test from baseline to follow-up.
Higher scores indicate better psychomotor speed.
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Baseline, Week 4, Month 3, and Month 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Albert KK Chung, Department of Psychiatry, The University of Hong Kong
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2028
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2026
Publicado por primera vez (Actual)
30 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UW 26-263
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
This is because of the potential legal consequences to the participants as etomidate abuse in the study locality is considered criminal.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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