{"doc_desc":{"title":"Cohort of Opioid-Dependent Subjects Starting Methadone Treatment","idno":"FRESH-PEF73307-en","producers":[{"name":"Maria Patrizia CARRIERI","affiliation":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73307-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73307"},{"agency":"FReSH","code":"FRESH-PEF73307"}]},"title":"Cohort of Opioid-Dependent Subjects Starting Methadone Treatment","alternate_title":"M\u00e9thaville ANRS (Agency for Research on AIDS and Viral Hepatitis)"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Maria Patrizia;CARRIERI","PILabo":"","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","extlink":[{"title":"ORCID","uri":"0000-0002-6794-4837","role":"pi id"},{"title":"IdRef","uri":"144323036","role":"pi id"},{"title":"SIREN","uri":"330065095","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"maria-patrizia.carrieri@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Maria Patrizia;CARRIERI","email":"maria-patrizia.carrieri@inserm.fr","type":"contact","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","contactPointLabo":"","extlink":[{"uri":"330065095","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"methadone"},{"keyword":"opioids"},{"keyword":"buprenorphine"},{"keyword":"cannabis and other illicit substances"},{"keyword":"treatment"},{"keyword":"addiction"}],"topics":[{"topic":"General medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Opioid dependence","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1120716949","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To compare the non-inferiority of daily opioid use after one year of treatment (trial phase) in opiate-dependent patients that began methadone treatment through two different arms: private care versus specialised centres for substance dependence (CSAPA). After stabilising the prescribed methadone dose, patients may select the treatment location from the centres and investigators included in the study (2 initial arms may result in 4 possible groups). Secondary aims involve comparing the prevalence of HCV risk behaviours and treatment effectiveness among the groups during a 3-year follow-up in terms of: treatment adherence; prevalence of addictive behaviours; improvement in social insertion and quality of life; prevalence of psychiatric comorbidities; reduction in criminal acts; treatment satisfaction and cost effectiveness.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Opioid\\\/opiate users wishing to enter a methadone programme.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nQuality of life\/health perception\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access not yet planned","sources":[],"target_sample_size":"< 500 individuals","response_rate":"221"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Metadata-only access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"22-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"29-06-2016","isContributorPI":"No","contributorName":"Maria Patrizia CARRIERI","contributorAffiliation":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28Methadone+Maintenance+Treatment+AND+opioid-dependent+AND++Carrieri+MP+[Author]%29+OR+M%C3%A9thaville"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"By participating physicians (private and CSAPA)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Health episodes; withdrawal symptoms; depressive episodes and suicide risk; pain","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}