<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/NCT04424459</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0132</org_study_id>
    <nct_id>NCT04424459</nct_id>
  </id_info>
  <brief_title>Evaluation of an Opioid Decrease Strategy in Chronic</brief_title>
  <acronym>EODSCPP</acronym>
  <official_title>Evaluation of an Opioid Decrease Strategy in Chronic Pain Patients at the Pain Assessment and Treatment Center in Montpellier: Prospective Study Over 6 Months.</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>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>
      Increase in the consumption of analgesics observed in many countries with a mediatic crisis&#xD;
      resulting in an increasingly frequent wish of patients to wean themselves from opiates. A&#xD;
      recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic&#xD;
      treatment, the patient should be informed of the risk of opioid dependence and misuse. There&#xD;
      is no clearly validated decay scheme in the event of dependence in patients with Chronic&#xD;
      Non-Cancer Pain.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        -  Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the&#xD;
           risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and&#xD;
           information sheet on chronic pain, treatments and risk of DOP, pharmacological and&#xD;
           nonpharmacological adaptation)&#xD;
&#xD;
        -  Highlight the need for additional information from patients and prescribers on the risk&#xD;
           of DOP and MOP in DCNC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main objective: Check if the rapid to semi-rapid regimen (- 25 to -60% dosage in 5 days of&#xD;
      HDS) of opioid analgesics, without the use of methadone or buprenorphine agonists, in the&#xD;
      case of DCNC at the CETD in Montpellier is efficient in the medium term (6 months).&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
        -  With our inclusion questionnaire we wanted to check if the patients had been made aware&#xD;
           of the risk of opiate dependence and misuse.&#xD;
&#xD;
        -  Detect the conditions of prescriptions that can promote the misuse of opiates.&#xD;
&#xD;
        -  Evaluating the different components of residual pain at 6 months (type, intensity,&#xD;
           anxiety component and depression, function).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the dosage of opioid and co-analgesic treatments</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Change of the dosage of opioid and co-analgesic treatments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring quality of life</measure>
    <time_frame>Inclusion, 3 and 6 months</time_frame>
    <description>interview with the patient</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Patients included from 10/01/19 to 12/31/19.</arm_group_label>
    <description>Patients included from 10/01/19 to 12/31/19. (the study will be extended to a larger number of patients according to the first results), continued according to the first results. DCNC patients treated at the Montpellier Pain Assessment and Treatment Center hospitalized during the period from 10/01/19 to 12/31/19, for misuse of opioid treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opioid withdrawal</intervention_name>
    <description>The data retrieved from the patient will be encrypted and there will also be written data or written in binary form. They will be used to create an Excel table which allows me to list the data on D1 then on M + 3 then on M + 6 in order to evaluate the evolution of these data over a time interval of 6 months and this is which will be used as support in my thesis in pharmacy.</description>
    <arm_group_label>Patients included from 10/01/19 to 12/31/19.</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      NC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        DCNC patients treated at the Montpellier Pain Assessment and Treatment Center hospitalized&#xD;
        during the period from 10/01/19 to 12/31/19, for misuse of opioid treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  chronic pain patient&#xD;
&#xD;
          -  major&#xD;
&#xD;
          -  supported at CETD&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        -patient with physical and mental incapacity to participate in the study&#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>Théa GENDARME, MD, PharmD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH 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>December 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid analgesics</keyword>
  <keyword>Opioid use disorders</keyword>
  <keyword>Prescription drug abuse</keyword>
  <keyword>treatments Prevention Identification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT04424459
org study id: RECHMPL20_0132
nct id: NCT04424459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Increase in the consumption of analgesics observed in many countries with a mediatic crisis
      resulting in an increasingly frequent wish of patients to wean themselves from opiates. A
      recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic
      treatment, the patient should be informed of the risk of opioid dependence and misuse. There
      is no clearly validated decay scheme in the event of dependence in patients with Chronic
      Non-Cancer Pain.

      Hypotheses:

        -  Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the
           risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and
           information sheet on chronic pain, treatments and risk of DOP, pharmacological and
           nonpharmacological adaptation)

        -  Highlight the need for additional information from patients and prescribers on the risk
           of DOP and MOP in DCNC.
Main objective: Check if the rapid to semi-rapid regimen (- 25 to -60% dosage in 5 days of
      HDS) of opioid analgesics, without the use of methadone or buprenorphine agonists, in the
      case of DCNC at the CETD in Montpellier is efficient in the medium term (6 months).

      Secondary objective:

        -  With our inclusion questionnaire we wanted to check if the patients had been made aware
           of the risk of opiate dependence and misuse.

        -  Detect the conditions of prescriptions that can promote the misuse of opiates.

        -  Evaluating the different components of residual pain at 6 months (type, intensity,
           anxiety component and depression, function).
observational model: Case-Control
time perspective: Prospective
measure: Change of the dosage of opioid and co-analgesic treatments
time frame: 3 months and 6 months
description: Change of the dosage of opioid and co-analgesic treatments
measure: Measuring quality of life
time frame: Inclusion, 3 and 6 months
description: interview with the patient
arm group label: Patients included from 10/01/19 to 12/31/19.
description: Patients included from 10/01/19 to 12/31/19. (the study will be extended to a larger number of patients according to the first results), continued according to the first results. DCNC patients treated at the Montpellier Pain Assessment and Treatment Center hospitalized during the period from 10/01/19 to 12/31/19, for misuse of opioid treatment.
intervention type: Drug
intervention name: opioid withdrawal
description: The data retrieved from the patient will be encrypted and there will also be written data or written in binary form. They will be used to create an Excel table which allows me to list the data on D1 then on M + 3 then on M + 6 in order to evaluate the evolution of these data over a time interval of 6 months and this is which will be used as support in my thesis in pharmacy.
arm group label: Patients included from 10/01/19 to 12/31/19.
NC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Théa GENDARME, MD, PharmD, MSc
role: Principal Investigator
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Analgesics, Opioid
sharing ipd: Undecided
ipd description: NC