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Completed

NCT Number: NCT02950376

The Novel Addiction Assessment Study in Synthetic Drugs Addiction

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSM-5 +Virtual reality-based addiction assessment system

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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

  1. The Diagnostic and Statistical Manual of Mental Disorders(DSM)

    Time frame: baseline

    To establish the criterion validity

  2. Addiction Severity Index(ASI)

    Time frame: baseline

    To establish the criterion validity

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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