The Novel Addiction Assessment Study in Synthetic Drugs Addiction

Amphetamine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950376
• Other study ID #: MZhao-006
• Status: Completed
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders
• Behavior, Addictive
• Substance-Related Disorders

Intervention

Other:
• DSM-5 +Virtual reality-based addiction assessment system
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.
• Virtual reality-based addiction assessment system
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.
• DSM-5 +Virtual reality-based addiction assessment system
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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The Diagnostic and Statistical Manual of Mental Disorders(DSM)	To establish the criterion validity	baseline
Secondary	Addiction Severity Index(ASI)	To establish the criterion validity	baseline