The Novel Addiction Assessment Study in Synthetic Drugs Addiction

NCT02950376 | Completed

• 1 other identifier: MZhao-006
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine Addiction

Keywords

synthetic drugs; virtual reality; addiction evaluation; physiological data; eye movement index

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The Diagnostic and Statistical Manual of Mental Disorders（DSM）

  baseline

• Addiction Severity Index(ASI)

  baseline

Study Arms (3)

Group1：amphetamine abusers

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

Group2: health control

Other: Virtual reality-based addiction assessment system

Group3: norm of assessment system

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

Interventions

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.

Group1：amphetamine abusers

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.

Group2: health control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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:
• 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.
• History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
• Intelligence quotient less than 70.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Min Zhao, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)