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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
Change in etomidate craving
Change in craving measured by the Craving Automated Scale-Substance from baseline to follow-up. Higher scores indicate stronger craving.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6
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.
Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6
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.
Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6
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.
Time frame: Baseline, Week 4, Month 3, and Month 6
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.
Time frame: Baseline, Week 4, Month 3, and Month 6
Change in global cognitive function
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.
Time frame: Baseline, Week 4, Month 3, and Month 6
Change in psychomotor speed
Change in psychomotor speed measured by the Digit Symbol Substitution Test from baseline to follow-up. Higher scores indicate better psychomotor speed.
Time frame: Baseline, Week 4, Month 3, and Month 6
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