xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021548</url>
    </required_header>
    <id_info>
      <org_study_id>8668</org_study_id>
      <nct_id>NCT06021548</nct_id>
    </id_info>
    <brief_title>Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach</brief_title>
    <acronym>BEBOP</acronym>
    <official_title>Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Strasbourg, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Strasbourg, France</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Opioid use disorder (OUD) is a chronic and severe psychiatric condition, defined by&#xD;
        problematic opioid use, that significantly impairs interpersonal and social functioning. Over&#xD;
        the last 10 years, a dramatic increase in the prevalence of OUD and deaths by overdose has&#xD;
        occurred in several developed countries, in particular the USA. In France, similarly, the&#xD;
        burden associated with OUD is worsening, and now represents a major public health crisis.&#xD;
        During last decades, it has been demonstrated that OUD results from combined effects of&#xD;
        numerous factors, which have been robustly identified across a variety of research fields,&#xD;
        including psychiatry, sociology, and neurobiology. This plurality is embodied in a&#xD;
        comprehensive theoretical framework, the biopsychosocial model of addiction, composed of&#xD;
        elements whose effects have been well defined individually, but remain poorly characterized&#xD;
        and understood in combination. More recently, behavioral epigenetics has emerged as a&#xD;
        promising discipline to identify molecular mechanisms that may help explain how life&#xD;
        experiences, in particular psychiatric and sociological factors, modulate the regulation of&#xD;
        genes, brain function, and emotional regulation. In this context, here we propose a&#xD;
        multidisciplinary project that builds on the collaboration of psychiatrists, sociologists and&#xD;
        neuro-epigeneticists. The investigators will simultaneously characterize major psychiatric&#xD;
        and social factors in a large cohort of individuals with OUD, with the goal of covering the&#xD;
        full spectrum of disease severity. By combining deep psychosocial evaluation with the&#xD;
        investigation of blood-derived epigenetic biomarkers, they will seek to provide a new and&#xD;
        deeper understanding of determinants of OUD severity.&#xD;
  &#xD;
        The project builds on 3 main hypotheses:&#xD;
  &#xD;
          1. Social and psychiatric factors together contribute to OUD severity;&#xD;
  &#xD;
          2. Epigenetic mechanisms, measured in peripheral accessible tissues such as blood,&#xD;
             represent biomarkers that may reflect pathophysiological processes resulting, at least&#xD;
             in part, from the effects of psychosocial factors;&#xD;
  &#xD;
          3. Measures of OUD severity combining both psychosocial factors and epigenetic biomarkers&#xD;
             have the potential to improve our ability to describe OUD severity, and better predict&#xD;
             its clinical course.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        First aim of the study is to systematically characterize OUD severity (DSM-5 criteria) and&#xD;
        psychosocial factors in N=350 individuals with OUD, recruited at Safe Injection Sites (SIS),&#xD;
        and other addiction-related facilities: French low-risk consumption room (CSAPA), Center for&#xD;
        Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD), and pain treatment&#xD;
        centers.&#xD;
  &#xD;
        Recruitment at SIS will allow to target OUD patients at highest psychosocial risk, who&#xD;
        remained mostly out-of-reach of previous studies, and to compare them to stabilized OUD&#xD;
        patients, overall covering a wide spectrum of disease course and severity.&#xD;
  &#xD;
        Second aim of the study is to examine genome-wide epigenetic regulation (DNA methylation) and&#xD;
        gene expression in peripheral blood samples collected from all subjects, at inclusion; then,&#xD;
        to leverage systems biology to characterize relationships among these molecular measures and&#xD;
        OUD and psychosocial severity;&#xD;
  &#xD;
        Third aim of the study is to assess the evolution of OUD and psychosocial severity in the&#xD;
        whole cohort, over 2 years, in order to determine how such evolution can be predicted using&#xD;
        molecular epigenetic biomarkers defined at inclusion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">May 14, 2029</completion_date>
    <primary_completion_date type="Anticipated">May 14, 2029</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD</measure>
      <time_frame>At inclusion</time_frame>
      <description>Opioid users will be recruitedat Safe Injection Sites (SIS) where we are privileged access, and others addiction related facilities (French CSAPA,CAARUD, and pain treatment centers. Recruitment at SIS will allow the investigators to target OUD patients at highest psychosocial risk, who remained mostly out-of-reach of previous studies, and to compare them to stabilized OUD patients, overall covering a wide spectrum of desease course and severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Examine genome -wide epigenic regulation and gene expression in peripheral blood samples collected from all subjects, at inclusion assess the evolution of OUD and psychosocial severity in the cohort, over 2 years.</measure>
      <time_frame>At inclusion and 24 month after inclusion</time_frame>
      <description>Two secondary outcome will be measured (1) The investigators want to examine genome -wide epigenic regulation (DNA methylation) and gene expression in peripheral blood samples collected from all subjects, at inclusion; then to leverage systems biology to characterize relationships among these molecular measures and OUD and psychosocial severity (2) The investigators want to assess the evolution of OUD and psychosocial severirity in the whole cohort, over 2 years, in order to determine how such evolution can be predicted using molecular epigenic biomarkers defined at inclusion</description>
    </secondary_outcome>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Opioid Use Disorder</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Finger stick blood spots will be collected at V0 and M12</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Saliva sample</intervention_name>
      <description>Saliva sample will be collected at V0</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hair sample</intervention_name>
      <description>Hair sample will be collected at V0 (optional)</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        The samples will be taken by finger prick and blood collection (between 200 and 500&#xD;
        microliters per sample) on a capillary tube in order to avoid generating a craving by using&#xD;
        phlebotomy to collect venous blood.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be recruited:&#xD;
  &#xD;
            -  in the 2 SIS in Paris (Gaia) and Strasbourg (Ithaque),&#xD;
  &#xD;
            -  in French addiction care centers: CAARUD (harm reduction services for drugs users) and&#xD;
               CSAPA (primary care outpatient settings for patients with addiction) in Strasbourg,&#xD;
               Paris and Lyon&#xD;
  &#xD;
            -  in Pain treatment centers in Strasbourg and Lyon.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male, female, or transgender person, age &gt; 18 years&#xD;
  &#xD;
            -  French speaking subject, able to understand the objectives and risks of the research&#xD;
  &#xD;
            -  Informed signed consent form by the curator (subject under curatorship) / guardian&#xD;
               (subject under guardianship), if applicable&#xD;
  &#xD;
            -  Subject who has written &quot;I consent&quot; on the consent form&#xD;
  &#xD;
            -  Subject using psychoactive substances and who attends a low-risk consumption room&#xD;
               (SCMR), or a Center for Care, Accompaniment and Prevention in Addictology (CSAPA), or&#xD;
               a Center for Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD)&#xD;
  &#xD;
            -  Subject who used one or more illegal opioid drugs or one or more medications (with or&#xD;
               without a prescription) at least once in the last 3 months (heroin, buprenorphine,&#xD;
               morphine sulfate, methadone, morphine derivatives, oxycontin, oxycodone, oxynorm,&#xD;
               Subutex® (Sub), Temgesic®, Suboxone®, Orobupre®, Skenan®, Moscontin®, opium,&#xD;
               pethidine, codeine, dinacode, neocodion, codeine efferalgan, Lamaline®, tramadol,&#xD;
               durogesic patches, fentanyl...)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to give the subject informed information (subject with difficulties in&#xD;
               understanding)&#xD;
  &#xD;
            -  Subject in an emergency or life-threatening situation&#xD;
  &#xD;
            -  Subject under court protection (upon subject's declaration)&#xD;
  &#xD;
            -  Subject participating in an investigational drug study (upon subject's declaration)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Laurence LALANNE, MD</last_name>
      <phone>33.3.88.11.51.35</phone>
      <email>laurence.lalanne@chru-strasbourg.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pierre Eric LUTZ</last_name>
      <phone>33.3.88.45.67.29</phone>
      <email>pierreeric.lutz@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Service Universitaire d'Addictologie, Hospices Civils de Lyon</name>
        <address>
          <city>Bron</city>
          <zip>69678</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Benjamin ROLLAND, MD</last_name>
        <phone>33.4.37.91.55.55</phone>
        <email>benjamin.rolland@ch-le-vinatier.fr</email>
      </contact>
      <investigator>
        <last_name>Benjamin ROLLAND, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mathieu CHAPPUY, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ismahane MERAH, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)</name>
        <address>
          <city>Paris</city>
          <zip>75006</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie JAUFFRET-ROUSTIDE</last_name>
        <phone>33.6.10.55.32.87</phone>
        <email>marie.jauffret-roustide@inserm.fr</email>
      </contact>
      <investigator>
        <last_name>Marie JAUFFRET-ROUSTIDE</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mireille LEBRETON</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Service d'Addictologie, Hôpitaux Universitaires de Strasbourg</name>
        <address>
          <city>Strasbourg</city>
          <zip>67091</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Laurence LALANNE, MD</last_name>
        <phone>33.3.88.11.51.35</phone>
        <email>laurence.lalanne@chru-strasbourg.fr</email>
      </contact>
      <investigator>
        <last_name>Flavie OSTER, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Camille BRAND, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sophie HENCK, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laurence LALANNE, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Psychiatry, Neurobiology, Epidemiology, Bioinformatics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021548
  org study id: 8668
  nct id: NCT06021548
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Opioid use disorder (OUD) is a chronic and severe psychiatric condition, defined by
        problematic opioid use, that significantly impairs interpersonal and social functioning. Over
        the last 10 years, a dramatic increase in the prevalence of OUD and deaths by overdose has
        occurred in several developed countries, in particular the USA. In France, similarly, the
        burden associated with OUD is worsening, and now represents a major public health crisis.
        During last decades, it has been demonstrated that OUD results from combined effects of
        numerous factors, which have been robustly identified across a variety of research fields,
        including psychiatry, sociology, and neurobiology. This plurality is embodied in a
        comprehensive theoretical framework, the biopsychosocial model of addiction, composed of
        elements whose effects have been well defined individually, but remain poorly characterized
        and understood in combination. More recently, behavioral epigenetics has emerged as a
        promising discipline to identify molecular mechanisms that may help explain how life
        experiences, in particular psychiatric and sociological factors, modulate the regulation of
        genes, brain function, and emotional regulation. In this context, here we propose a
        multidisciplinary project that builds on the collaboration of psychiatrists, sociologists and
        neuro-epigeneticists. The investigators will simultaneously characterize major psychiatric
        and social factors in a large cohort of individuals with OUD, with the goal of covering the
        full spectrum of disease severity. By combining deep psychosocial evaluation with the
        investigation of blood-derived epigenetic biomarkers, they will seek to provide a new and
        deeper understanding of determinants of OUD severity.
  
        The project builds on 3 main hypotheses:
  
          1. Social and psychiatric factors together contribute to OUD severity;
  
          2. Epigenetic mechanisms, measured in peripheral accessible tissues such as blood,
             represent biomarkers that may reflect pathophysiological processes resulting, at least
             in part, from the effects of psychosocial factors;
  
          3. Measures of OUD severity combining both psychosocial factors and epigenetic biomarkers
             have the potential to improve our ability to describe OUD severity, and better predict
             its clinical course.
  First aim of the study is to systematically characterize OUD severity (DSM-5 criteria) and
        psychosocial factors in N=350 individuals with OUD, recruited at Safe Injection Sites (SIS),
        and other addiction-related facilities: French low-risk consumption room (CSAPA), Center for
        Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD), and pain treatment
        centers.
  
        Recruitment at SIS will allow to target OUD patients at highest psychosocial risk, who
        remained mostly out-of-reach of previous studies, and to compare them to stabilized OUD
        patients, overall covering a wide spectrum of disease course and severity.
  
        Second aim of the study is to examine genome-wide epigenetic regulation (DNA methylation) and
        gene expression in peripheral blood samples collected from all subjects, at inclusion; then,
        to leverage systems biology to characterize relationships among these molecular measures and
        OUD and psychosocial severity;
  
        Third aim of the study is to assess the evolution of OUD and psychosocial severity in the
        whole cohort, over 2 years, in order to determine how such evolution can be predicted using
        molecular epigenetic biomarkers defined at inclusion.
  observational model: Case-Only
  time perspective: Prospective
  measure: To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD
  time frame: At inclusion
  description: Opioid users will be recruitedat Safe Injection Sites (SIS) where we are privileged access, and others addiction related facilities (French CSAPA,CAARUD, and pain treatment centers. Recruitment at SIS will allow the investigators to target OUD patients at highest psychosocial risk, who remained mostly out-of-reach of previous studies, and to compare them to stabilized OUD patients, overall covering a wide spectrum of desease course and severity.
  measure: Examine genome -wide epigenic regulation and gene expression in peripheral blood samples collected from all subjects, at inclusion assess the evolution of OUD and psychosocial severity in the cohort, over 2 years.
  time frame: At inclusion and 24 month after inclusion
  description: Two secondary outcome will be measured (1) The investigators want to examine genome -wide epigenic regulation (DNA methylation) and gene expression in peripheral blood samples collected from all subjects, at inclusion; then to leverage systems biology to characterize relationships among these molecular measures and OUD and psychosocial severity (2) The investigators want to assess the evolution of OUD and psychosocial severirity in the whole cohort, over 2 years, in order to determine how such evolution can be predicted using molecular epigenic biomarkers defined at inclusion
  intervention type: Other
  intervention name: Blood sample
  description: Finger stick blood spots will be collected at V0 and M12
  intervention type: Other
  intervention name: Saliva sample
  description: Saliva sample will be collected at V0
  intervention type: Other
  intervention name: Hair sample
  description: Hair sample will be collected at V0 (optional)
  The samples will be taken by finger prick and blood collection (between 200 and 500
        microliters per sample) on a capillary tube in order to avoid generating a craving by using
        phlebotomy to collect venous blood.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laurence LALANNE, MD
  phone: 33.3.88.11.51.35
  email: laurence.lalanne@chru-strasbourg.fr
  last name: Pierre Eric LUTZ
  phone: 33.3.88.45.67.29
  email: pierreeric.lutz@gmail.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Opioid-Related Disorders
  sharing ipd: No