The Novel Addiction Assessment Study in Synthetic Drugs Addiction
6 janvier 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
1500
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Shanghai
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Shanghai, Shanghai, Chine
- Shanghai Mental Health Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group1：amphetamine abusers
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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.
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Group2: health control
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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.
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Group3: norm of assessment system
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes of physiological indexs
Délai: In 1 year
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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.
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In 1 year
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Changes of eye movement index
Délai: In 1 year
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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.
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In 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Diagnostic and Statistical Manual of Mental Disorders（DSM）
Délai: baseline
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To establish the criterion validity
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baseline
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Addiction Severity Index(ASI)
Délai: baseline
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To establish the criterion validity
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baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Min Zhao, PhD, Shanghai Mental Health Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2016
Achèvement primaire (Réel)
1 décembre 2018
Achèvement de l'étude (Réel)
1 décembre 2018
Dates d'inscription aux études
Première soumission
23 octobre 2016
Première soumission répondant aux critères de contrôle qualité
27 octobre 2016
Première publication (Estimation)
1 novembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MZhao-006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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