Novel Intervention for Amphetamine-type Stimulants Addiction

Study Overview
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Brief Summary
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The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.

Detailed Description
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The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.

Official Title
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The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction

Conditions
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Amphetamine Addiction

Intervention / Treatment
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* Radiation: repetitive transcranial magnetic stimulation (rTMS)
* Radiation: sham repetitive transcranial magnetic stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders Dextromanual Exclusion Criteria: Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc Have cognitive-promoting drugs in the last 6 months Other substance abuse or dependence in recent five years (except nicotine) Mental impairment, Intelligence Quotient (IQ) < 70 Mental disorders Physical disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control group<br>sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. | Radiation: sham repetitive transcranial magnetic stimulation (rTMS)<br>* Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day<br>|
| Active Comparator: rTMS group<br>Use randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms. | Radiation: repetitive transcranial magnetic stimulation (rTMS)<br>* Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month | evaluate all participants' craving for ATS by Visual Analog Scales (VAS) | Baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who relapse | Follow up with patients after discharge, evaluate number of participants who relapse | 1 month | 
| Depression status assessed by Patient Health Questionnaire-9(PHQ-9) | evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9) | 1 month | 
| Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7) | evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7) | 1 month | 
| Cognitive function assessed by Cogstate Battery | evaluate all participants' cognition by Cogstate Battery Chinese version | 1 month | 
| Functional connectivity assessed by MRI | evaluate all participants' functional connectivity in the brain by MRI | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, Glutamate/GABA, motivational and cognitive intervention