Repetitive Transcranial Magnetic Stimulation for People With Etomidate Addiction (SToP-E-rTMS x Etomidate)
SToP-E
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
1 other identifier
interventional
40
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
Study Completion
Last participant's last visit for all outcomes
March 31, 2029
July 30, 2026
July 1, 2026
2 years
July 26, 2026
July 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in etomidate craving
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
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
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
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
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
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
Secondary Outcomes (6)
Change in anxiety symptoms
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in depressive symptoms
Baseline, Week 1, Week 4, Month 3, and Month 6
Change in delayed reward discounting
Baseline, Week 4, Month 3, and Month 6
Change in risk sensitivity
Baseline, Week 4, Month 3, and Month 6
Change in global cognitive function
Baseline, Week 4, Month 3, and Month 6
- +1 more secondary outcomes
Study Arms (2)
Active rTMS
EXPERIMENTALSubjects receive 20 high-frequency rTMS sessions over 4 weeks.
Sham rTMS
SHAM COMPARATORSubjects receive 20 Sham rTMS sessions over 4 weeks.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age \< 18 years old
- Unable to read English or Chinese
- Unable to give informed consent
- Had been diagnosed with the following disorders including:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong, 000000, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert KK Chung
Department of Psychiatry, The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2026
First Posted
July 30, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
This is because of the potential legal consequences to the participants as etomidate abuse in the study locality is considered criminal.