About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
Age < 18 years old
Unable to read English or Chinese
Unable to give informed consent
DSM-5: Intellectual Disabilities, Communication Disorders, Specific Learning Disorder, Autism Spectrum Disorder and Motor Disorders
Trial design
Parallel
Treatments tested in this trial
high-frequency Repetitive Transcranial Magnetic Stimulation
Devicehigh-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
Repetitive transcranial magnetic stimulation
DeviceSham 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in etomidate craving
Change in craving measured by the Craving Automated Scale-Substance from baseline to follow-up. Higher scores indicate stronger craving.
Change in etomidate withdrawal symptoms
Change in withdrawal symptoms measured by the Clinical Institute Withdrawal Assessment for Benzodiazepines from baseline to follow-up.
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.
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.
Secondary outcomes
Change in anxiety symptoms
Change in anxiety symptoms measured by the Beck Anxiety Inventory from baseline to follow-up. Higher scores indicate more severe anxiety symptoms.
Change in depressive symptoms
Change in depressive symptoms measured by the Beck Depression Inventory-II from baseline to follow-up. Higher scores indicate more severe depressive symptoms.
Change in delayed reward discounting
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.
Change in risk sensitivity
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: