<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/NCT02245685</url>
  </required_header>
  <id_info>
    <org_study_id>BRD/07/07-M</org_study_id>
    <nct_id>NCT02245685</nct_id>
  </id_info>
  <brief_title>Longitudinal Followup of Patients Under Substitution Therapy From the Moment They Enter a Specialized Care Center for Addicts to the Period They Are Monitored by a General Practitioner Outside the Specialized Care Center</brief_title>
  <official_title>Longitudinal Followup of Patients Under Substitution Therapy From the Moment They Enter a Specialized Care Center for Addicts to the Period They Are Monitored by a General Practitioner Outside the Specialized Care Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Health Products Safety Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of&#xD;
      the plan underlines the need to improve practices and access to opioid substitution&#xD;
      treatment. Priority 3 stresses the importance of articulation and coordination between&#xD;
      specialized structures and community medicine to optimize the quality of care and to ensure&#xD;
      continuity in the followup of these patients. This study focuses on the followup of patients&#xD;
      under substitution therapy from the moment they enter a specialized care center for addicts&#xD;
      to the period they are monitored by a general practitioner outside the specialized care&#xD;
      center. The assessment described in this study should allow to harmonize and keep a&#xD;
      continuity in patient monitoring.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the severity score to heroin addiction (TMSP score)</measure>
    <time_frame>From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of the score of quality of life scale</measure>
    <time_frame>From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the severity score to heroin addiction (TMSP score)</measure>
    <time_frame>From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the score of quality of life scale</measure>
    <time_frame>From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">113</enrollment>
  <condition>Addiction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients under substitution therapy monitored in a specialized care center for addicts&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients entering a specialized medical care center for addicts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to sign the consent for participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascale JOLLIET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CSST &quot;La Rose des Vents&quot;</name>
      <address>
        <city>Saint-Nazaire</city>
        <zip>44600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Substitution Therapy</keyword>
  <keyword>Specialized Care Center for Addicts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02245685
org study id: BRD/07/07-M
nct id: NCT02245685
lead sponsor: 
collaborator: 
has dmc: No
This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of
      the plan underlines the need to improve practices and access to opioid substitution
      treatment. Priority 3 stresses the importance of articulation and coordination between
      specialized structures and community medicine to optimize the quality of care and to ensure
      continuity in the followup of these patients. This study focuses on the followup of patients
      under substitution therapy from the moment they enter a specialized care center for addicts
      to the period they are monitored by a general practitioner outside the specialized care
      center. The assessment described in this study should allow to harmonize and keep a
      continuity in patient monitoring.
observational model: Cohort
time perspective: Prospective
measure: Evolution of the severity score to heroin addiction (TMSP score)
time frame: From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)
measure: Evolution of the score of quality of life scale
time frame: From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)
measure: Evolution of the severity score to heroin addiction (TMSP score)
time frame: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
measure: Evolution of the score of quality of life scale
time frame: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pascale JOLLIET, MD
role: Principal Investigator
affiliation: Nantes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Behavior, Addictive