The Novel Addiction Assessment Study in Synthetic Drugs Addiction

Study Overview
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Brief Summary
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The purpose of this research is to develop an objective assessment based on the virtual reality techniques which is used for evaluate addiction severity.

Detailed Description
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In order to evaluate the addiction severity and the effect of rehabilitation objectively, this study develops a virtual environment model based on the virtual reality technique, making the subjects in a drug related or neutral scene , at the same time recording the physical signs and eye movements index. Reliability and validity of this system will also be tested in this study. And we will construct the norm of addiction assessment system in Shanghai .The evaluating system will be very beneficial to develop novel and practical assessment for synthetic durg related disorder, and provide a reference for other drug dependence diagnosis.

Official Title
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Development of Virtual Reality-Based Addiction Assessment System for Synthetic Drugs Addiction

Conditions
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Amphetamine Addiction

Intervention / Treatment
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* Other: DSM-5 +Virtual reality-based addiction assessment system
* Other: Virtual reality-based addiction assessment system
* Other: DSM-5 +Virtual reality-based addiction assessment system


Participation Criteria
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Eligibility Criteria
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Criteria for synthetic drug abusers: Inclusion Criteria: In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-4) for methamphetamine (MA) use disorders; Education level equal or more than 9 years; Have normal or corrected-to-normal vision; Have normal or corrected-to-normal hearing; Less than 3 months before last drug use; Exclusion Criteria: Current substance use (except nicotine or caffeine) ; History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、 head injury or other severe medication conditions; Intelligence quotient less than 70. Criteria for healthy control: Inclusion Criteria: Without schizophrenia family history; Without history of drug abuse; Education level equal or more than 9 years; Have normal or corrected-to-normal vision; Have normal or corrected-to-normal hearing. Exclusion Criteria: History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions; Intelligence quotient less than 70.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1：amphetamine abusers<br> | Other: DSM-5 +Virtual reality-based addiction assessment system<br>* The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity. And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the beginning of withdrawl、3 months later、 6 months later and 1 year later and record the information synchronously.<br>|
| Group2: health control<br> | Other: Virtual reality-based addiction assessment system<br>* The healthy controls will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the baseline and 1 month later and record the information synchronously.<br>|
| Group3: norm of assessment system<br> | Other: DSM-5 +Virtual reality-based addiction assessment system<br>* The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity. And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.In this group which is designed to construct the norm of assessment system, the test will record the information synchronously and proceed after baseline assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of physiological indexs | The physiological index including galvanic skin response、encephlogram and electromyogram will be used to evaluate the reliability and validity of the virtual reality based addiction assessment system, and construct the norms of assessment system as well. | In 1 year | 
| Changes of eye movement index | The eye movement index will be used to evaluate the reliability and validity of the virtual reality based addiction assessment system, and construct the norms of assessment system as well. | In 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Diagnostic and Statistical Manual of Mental Disorders（DSM） | To establish the criterion validity | baseline | 
| Addiction Severity Index(ASI) | To establish the criterion validity | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synthetic drugs, virtual reality, addiction evaluation, physiological data, eye movement index