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Clinical Trials/NCT02950376
NCT02950376CompletedNot Applicable

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

Shanghai Mental Health Center1 site in 1 country1,500 target enrollmentStarted: December 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,500
Locations
1
Primary Endpoint
Changes of physiological indexs

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • 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.

Outcomes

Primary Outcomes

Changes of physiological indexs

Time Frame: In 1 year

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.

Changes of eye movement index

Time Frame: In 1 year

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.

Secondary Outcomes

  • Addiction Severity Index(ASI)(baseline)
  • The Diagnostic and Statistical Manual of Mental Disorders(DSM)(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Min ZHAO

Vice President

Shanghai Mental Health Center

Study Sites (1)

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