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

Official title

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

Overview

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

Detailed description

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.

Interventions

• Device 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
• Device 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.

Primary outcome measures

• Change in etomidate craving [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in etomidate withdrawal symptoms [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in amount of etomidate use [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in frequency of etomidate use [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in severity of dependence [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in urine-confirmed etomidate use [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]

Secondary outcome measures (6)

• Change in anxiety symptoms [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in depressive symptoms [Time frame: Baseline, Week 1, Week 4, Month 3, and Month 6]
• Change in delayed reward discounting [Time frame: Baseline, Week 4, Month 3, and Month 6]
• Change in risk sensitivity [Time frame: Baseline, Week 4, Month 3, and Month 6]
• Change in global cognitive function [Time frame: Baseline, Week 4, Month 3, and Month 6]
• Change in psychomotor speed [Time frame: Baseline, Week 4, Month 3, and Month 6]

Eligibility criteria

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:

• 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Queen Mary Hospital — Hong Kong

Identifiers

NCT: NCT07736742 · UW 26-263

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗