The Novel Addiction Assessment Study in Synthetic Drugs Addiction

Development of Virtual Reality-Based Addiction Assessment System for 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.

Study Overview

• Status: Completed
• Conditions: Amphetamine Addiction
• Intervention / Treatment: Other: DSM-5 +Virtual reality-based addiction assessment system; Other: DSM-5 +Virtual reality-based addiction assessment system; Other: Virtual reality-based addiction assessment system

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 Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study includes the synthetic drug abusers and healthy control into the experiment.The drug abusers will be recruited from compulsory isolated detoxification centers and non compulsory isolated detoxification institutions.The healthy control will be recruited from the residential communities.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1：amphetamine abusers	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.; 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.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.
Group2: health control	Other: 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.
Group3: norm of assessment system	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.; 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.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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Min Zhao, PhD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 23, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: virtual reality; synthetic drugs; addiction evaluation; physiological data; eye movement index
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Behavior, Addictive; Amphetamine-Related Disorders
• Other Study ID Numbers: MZhao-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO