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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cross-sectional study assessing the prevalence of co-addictions in subjects receiving opioid substitution treatment: determination of the clinical and pharmacological profile</titl>
      <IDNo>FRESH-PEF73282-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES" role="">Marie GRALL-BRONNEC</producer>
    </prodStmt>
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      <version></version>
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  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cross-sectional study assessing the prevalence of co-addictions in subjects receiving opioid substitution treatment: determination of the clinical and pharmacological profile            </titl>
      <altTitl>
                    OPAL                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73282-en            </IDNo>
      <IDNo agency="PEF">
                    73282                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73282                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Marie GRALL-BRONNEC                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES">
        <ExtLink title="ROR" URI="https://ror.org/05c1qsg97" role="organisation id"/>
        <ExtLink title="SIREN" URI="264400136" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="Multicentric study in collaboration with the CHU de Brest, CHU d&#x2019;Angers, CH de Morlaix, CH G. R&#xE9;gnier de Rennes, CSAPA &amp;quot Le Triangle&amp;quot (Nantes), &amp;quot La m&#xE9;tairie&amp;quot (La Roche S / Yon) And &amp;quot La Rose des Vents&amp;quot (St Nazaire), the SMPR in Nantes and the Addictions Network of the Nantes Region (RTRN)" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES" email="marie.bronnec@chu-nantes.fr">
                    Marie;GRALL-BRONNEC
                                            <ExtLink title="ROR" URI="https://ror.org/05c1qsg97" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264400136" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Opioid dependence</keyword>
      <keyword vocab="" vocabURI="">
                    opioid substitution treatment</keyword>
      <keyword vocab="" vocabURI="">
                    psychoactive substance</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacokinetics</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacogenetics</keyword>
      <keyword vocab="" vocabURI="">
                    polymorphism</keyword>
      <keyword vocab="" vocabURI="">
                    cytochrome P450 2D6</keyword>
      <keyword vocab="" vocabURI="">
                    addictions</keyword>
      <keyword vocab="" vocabURI="">
                    pathological gambling</keyword>
      <topcClas vocab="health theme">
                        Psychiatry                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3de50dee-da1c-4791-a386-56bca24a5fed"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D011570"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Addiction medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/42d645e0-f58d-40ed-9917-5b227ff41a92"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000073316"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Mental, behavioural or neurodevelopmental disorders                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">assess the current prevalence of addictive comorbidities in opioid-dependent subjects who have been receiving opioid substitution therapy (OST) for at least 6 months.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2013-01-01"/>
      <collDate event="end" date="2016-01-01"/>
      <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 level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Adult  Treatment with methadone or buprenorphine (+/- naloxone) or morphine as a substitute, prescribed for opioid dependence  OST established for at least 6 months  Incarceration of less than one month if monitored by a Regional Medical and Psychological Service (SMPR) in prison  Good understanding of French, knowing how to read and write it.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Verification of data by a Clinical Study Technician and the consistency of data by the data cell when entering it into the computer database</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
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    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
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        <frameUnit>
          <unitType>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>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>263</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
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