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

26 lipca 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Albert KK Chung
  • Numer telefonu: +85260440993
  • E-mail: Chungkka@hku.hk

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Active rTMS
Subjects receive 20 high-frequency rTMS sessions over 4 weeks.
Urządzenie: 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
Pozorny komparator: Sham rTMS
Subjects receive 20 Sham rTMS sessions over 4 weeks.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in etomidate craving
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in anxiety symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The University of Hong Kong

Śledczy

  • Główny śledczy: Albert KK Chung, Department of Psychiatry, The University of Hong Kong

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 sierpnia 2028

Ukończenie studiów (Szacowany)

31 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

26 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 lipca 2026

Pierwszy wysłany (Rzeczywisty)

30 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UW 26-263

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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