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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • high-frequency Repetitive Transcranial Magnetic Stimulation

    Device

    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

  • Repetitive transcranial magnetic stimulation

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active rTMSExperimental treatment 1 intervention
Group B: Sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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