The Novel Addiction Assessment Study in Synthetic Drugs Addiction

Completed

• Conditions: Amphetamine Addiction
• Interventions: Other: DSM-5 +Virtual reality-based addiction assessment system; Other: Virtual reality-based addiction assessment system

• Registration Number: NCT02950376
• Lead Sponsor: Shanghai Mental Health Center

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 Timeline

• Study First Submitted: 2016-10-23
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-11-01
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1：amphetamine abusers	DSM-5 +Virtual reality-based addiction assessment system	-
Group3: norm of assessment system	DSM-5 +Virtual reality-based addiction assessment system	-
Group2: health control	Virtual reality-based addiction assessment system	-

Primary Outcome Measures

Name	Time	Method
Changes of physiological indexs	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	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 Outcome Measures

Name	Time	Method
Addiction Severity Index(ASI)	baseline	To establish the criterion validity
The Diagnostic and Statistical Manual of Mental Disorders（DSM）	baseline	To establish the criterion validity

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China