<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of Opioid-Dependent Subjects Starting Methadone Treatment</titl>
      <IDNo>FRESH-PEF73307-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)" role="">Maria Patrizia CARRIERI</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of Opioid-Dependent Subjects Starting Methadone Treatment            </titl>
      <altTitl>
                    Méthaville ANRS (Agency for Research on AIDS and Viral Hepatitis)                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73307-en            </IDNo>
      <IDNo agency="PEF">
                    73307                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73307                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Maria Patrizia CARRIERI                                                                                </AuthEnty>
      <AuthEnty affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)">
        <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)" email="maria-patrizia.carrieri@inserm.fr">
                    Maria Patrizia;CARRIERI
                                            <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    methadone</keyword>
      <keyword vocab="" vocabURI="">
                    opioids</keyword>
      <keyword vocab="" vocabURI="">
                    buprenorphine</keyword>
      <keyword vocab="" vocabURI="">
                    cannabis and other illicit substances</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <keyword vocab="" vocabURI="">
                    addiction</keyword>
      <topcClas vocab="health theme">
                        General medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4b9f8efb-68dd-45a1-b04c-d23d457d6898"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D058006"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Opioid dependence                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2012-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe clusion="I">Opioid/opiate users wishing to enter a methadone programme.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception
Others</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>221</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Metadata-only access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access not yet planned</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
