<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/NCT03297853</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0305</org_study_id>
    <nct_id>NCT03297853</nct_id>
  </id_info>
  <brief_title>Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics</brief_title>
  <official_title>Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The demand for addiction care for patients with addiction to analgesics increases with the&#xD;
      number of prescription of analgesics grade 2; this is a public health problem There is no&#xD;
      support for repositories to date in the context of addiction analgesics grade 2.&#xD;
&#xD;
      Risk factors of misuse as well as diagnostic tools were identified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The demand for addiction care for patients with addiction to analgesics increases with the&#xD;
      number of prescription of analgesics grade 2; this is a public health problem There is no&#xD;
      support for repositories to date in the context of addiction analgesics grade 2.&#xD;
&#xD;
      Risk factors of misuse as well as diagnostic tools were identified. The objectives of our&#xD;
      research are to determine the characteristics of the individuals suffering from an addiction&#xD;
      to analgesics of level 2 followed in consultation of addictology in the hospital of&#xD;
      Montpellier and Nimes and to describe the type of follow-up proposed to the patients in these&#xD;
      two centers. It is a retrospective and descriptive study.&#xD;
&#xD;
      As part of this research, we will solicit all the patients followed in consultation of&#xD;
      addictology or in hospitalization to the hospital of Montpellier or Nîmes for an addiction to&#xD;
      the analgesics of grade 2 between the 1st of January 2014 and the 10th of July 2017 with&#xD;
      requests of management for withdrawal or reduction of doses, opioid analgesics in the absence&#xD;
      of pain or in chronic non-cancer pain, opioid analgesics to avoid withdrawal syndrome or&#xD;
      hyperalgesia and consumptions chronic to dosages inadequate to the functional complaint&#xD;
      evaluated by the rhumatology or algology services.&#xD;
&#xD;
      The data are collected in the medical file at the two participating institutions (Montpellier&#xD;
      and Nîmes) and if necessary, patients not seen in consultation for more than 6 months will be&#xD;
      recontacted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>50/5000 Prevalence of demand for care in addictology</measure>
    <time_frame>1 day</time_frame>
    <description>Prevalence of demand for addictive care in subjects with addiction to analgesics in level 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Types of support proposed</measure>
    <time_frame>1 day</time_frame>
    <description>Types of support proposed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of analgesic dependence</measure>
    <time_frame>1 day</time_frame>
    <description>Assessment of analgesic dependence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of analgesic use</measure>
    <time_frame>1 day</time_frame>
    <description>History of analgesic use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>1 day</time_frame>
    <description>quality of life</description>
  </secondary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Analgesics Grade 2's Addiction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients attending addictology or hospitalization in Montpellier or Nîmes for an&#xD;
        addiction to analgesics grade 2 between the 1st ofJanuary 2014 and the 22th of january 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Requests for management for weaning or reduction of doses&#xD;
&#xD;
          -  Take opioid analgesics in the absence of pain or as part of chronic non-cancer pain&#xD;
&#xD;
          -  Opioid analgesics to prevent withdrawal syndrome or hyperalgesia&#xD;
&#xD;
          -  Chronic consumption at inadequate dosages compared to the functional complaint&#xD;
             evaluated by the MPR / Algologie services&#xD;
&#xD;
          -  Patients over 18 years and who agree with the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  language barrier&#xD;
&#xD;
          -  severe cognitive and / or psychiatric disorders&#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_official>
    <last_name>TARUFFI Floriane, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Descriptive</keyword>
  <keyword>Support</keyword>
  <keyword>Retrospective</keyword>
  <keyword>survey</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- 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/NCT03297853
org study id: RECHMPL17_0305
nct id: NCT03297853
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The demand for addiction care for patients with addiction to analgesics increases with the
      number of prescription of analgesics grade 2; this is a public health problem There is no
      support for repositories to date in the context of addiction analgesics grade 2.

      Risk factors of misuse as well as diagnostic tools were identified.
The demand for addiction care for patients with addiction to analgesics increases with the
      number of prescription of analgesics grade 2; this is a public health problem There is no
      support for repositories to date in the context of addiction analgesics grade 2.

      Risk factors of misuse as well as diagnostic tools were identified. The objectives of our
      research are to determine the characteristics of the individuals suffering from an addiction
      to analgesics of level 2 followed in consultation of addictology in the hospital of
      Montpellier and Nimes and to describe the type of follow-up proposed to the patients in these
      two centers. It is a retrospective and descriptive study.

      As part of this research, we will solicit all the patients followed in consultation of
      addictology or in hospitalization to the hospital of Montpellier or Nîmes for an addiction to
      the analgesics of grade 2 between the 1st of January 2014 and the 10th of July 2017 with
      requests of management for withdrawal or reduction of doses, opioid analgesics in the absence
      of pain or in chronic non-cancer pain, opioid analgesics to avoid withdrawal syndrome or
      hyperalgesia and consumptions chronic to dosages inadequate to the functional complaint
      evaluated by the rhumatology or algology services.

      The data are collected in the medical file at the two participating institutions (Montpellier
      and Nîmes) and if necessary, patients not seen in consultation for more than 6 months will be
      recontacted.
observational model: Other
time perspective: Retrospective
measure: 50/5000 Prevalence of demand for care in addictology
time frame: 1 day
description: Prevalence of demand for addictive care in subjects with addiction to analgesics in level 2
measure: Types of support proposed
time frame: 1 day
description: Types of support proposed
measure: Assessment of analgesic dependence
time frame: 1 day
description: Assessment of analgesic dependence
measure: History of analgesic use
time frame: 1 day
description: History of analgesic use
measure: quality of life
time frame: 1 day
description: quality of life
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: TARUFFI Floriane, Doctor
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Behavior, Addictive
sharing ipd: Undecided
ipd description: NC