The Novel Addiction Assessment Study in Synthetic Drugs Addiction
6 januari 2020 bijgewerkt door: Min ZHAO, Shanghai Mental Health Center
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
1500
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Shanghai
-
Shanghai, Shanghai, China
- Shanghai Mental Health Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Group1：amphetamine abusers
|
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.
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
|
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
|
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.
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes of physiological indexs
Tijdsspanne: 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.
|
In 1 year
|
|
Changes of eye movement index
Tijdsspanne: 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.
|
In 1 year
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The Diagnostic and Statistical Manual of Mental Disorders（DSM）
Tijdsspanne: baseline
|
To establish the criterion validity
|
baseline
|
|
Addiction Severity Index(ASI)
Tijdsspanne: baseline
|
To establish the criterion validity
|
baseline
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Min Zhao, PhD, Shanghai Mental Health Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2016
Primaire voltooiing (Werkelijk)
1 december 2018
Studie voltooiing (Werkelijk)
1 december 2018
Studieregistratiedata
Eerst ingediend
23 oktober 2016
Eerst ingediend dat voldeed aan de QC-criteria
27 oktober 2016
Eerst geplaatst (Schatting)
1 november 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 januari 2020
Laatste update ingediend die voldeed aan QC-criteria
6 januari 2020
Laatst geverifieerd
1 januari 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MZhao-006
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op DSM-5 +Virtual reality-based addiction assessment system
-
Mahidol UniversityVoltooidScreeningstool voor depressie bij patiënten met kankerpijnThailand