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

26 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Albert KK Chung
  • Numero di telefono: +85260440993
  • Email: Chungkka@hku.hk

Luoghi di studio

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 000000

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active rTMS
Subjects receive 20 high-frequency rTMS sessions over 4 weeks.
Dispositivo: 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
Comparatore fittizio: Sham rTMS
Subjects receive 20 Sham rTMS sessions over 4 weeks.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in etomidate craving
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in anxiety symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Hong Kong

Investigatori

  • Investigatore principale: Albert KK Chung, Department of Psychiatry, The University of Hong Kong

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 marzo 2029

Date di iscrizione allo studio

Primo inviato

26 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UW 26-263

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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