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The Novel Addiction Assessment Study in Synthetic Drugs Addiction

This study is not yet open for participant recruitment.
Verified October 2016 by Min ZHAO, Shanghai Mental Health Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02950376
First Posted: November 1, 2016
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Min ZHAO, Shanghai Mental Health Center
  Purpose
The purpose of this research is to develop an objective assessment based on the virtual reality techniques which is used for evaluate addiction severity.

Condition Intervention
Amphetamine Addiction Other: DSM-5 +Virtual reality-based addiction assessment system Other: Virtual reality-based addiction assessment system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of Virtual Reality-Based Addiction Assessment System for Synthetic Drugs Addiction

Resource links provided by NLM:


Further study details as provided by Min ZHAO, Shanghai Mental Health Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • The Diagnostic and Statistical Manual of Mental Disorders(DSM) [ Time Frame: baseline ]
    To establish the criterion validity

  • Addiction Severity Index(ASI) [ Time Frame: baseline ]
    To establish the criterion validity


Estimated Enrollment: 1500
Study Start Date: December 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950376


Contacts
Contact: Min Zhao, PhD 021-54252689 18017311005@163.com

Locations
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: Min Zhao, PhD Shanghai Mental Health Center
  More Information

Responsible Party: Min ZHAO, Vice President, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02950376     History of Changes
Other Study ID Numbers: MZhao-006
First Submitted: October 23, 2016
First Posted: November 1, 2016
Last Update Posted: May 2, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Min ZHAO, Shanghai Mental Health Center:
synthetic drugs
virtual reality
addiction evaluation
physiological data
eye movement index

Additional relevant MeSH terms:
Behavior, Addictive
Substance-Related Disorders
Amphetamine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors