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/NCT05976178</url>
    </required_header>
    <id_info>
      <org_study_id>56LORC_2021_ADDICTALGO</org_study_id>
      <nct_id>NCT05976178</nct_id>
    </id_info>
    <brief_title>Study of the Characteristics of Chronic Pain in Patients With Addiction</brief_title>
    <acronym>ADDICTALGO</acronym>
    <official_title>Descriptive, Prospective Study of the Characteristics of Chronic Pain in Patients With Addiction to at Least One Substance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Groupe Hospitalier de Bretagne Sud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Groupe Hospitalier de Bretagne Sud</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>
        It is described in the literature a higher prevalence of pain in patients with an addiction&#xD;
        but there are few studies describing the pain profile of patients with use disorder.&#xD;
  &#xD;
        Pain has a very negative impact on the quality of life of opioid substituted patients.&#xD;
        Improving knowledge on this point would make it possible to better guide specific care.&#xD;
  &#xD;
        The investigator proposes to conduct a single-center descriptive observational study using&#xD;
        questionnaires, without changing the management of patients with chronic pain.&#xD;
  &#xD;
        The primary objective of the study is to determine the prevalence of chronic pain in patients&#xD;
        with substance addiction hospitalized for addiction treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is described in the literature a higher prevalence of pain in patients with an addiction&#xD;
        but there are few studies describing the pain profile of patients with use disorder.&#xD;
  &#xD;
        Pain has a very negative impact on the quality of life of opioid substituted patients.&#xD;
        Improving knowledge on this point would make it possible to better guide specific care.&#xD;
  &#xD;
        The investigator proposes to conduct a single-center descriptive observational study using&#xD;
        questionnaires, without changing the management of patients with chronic pain. All patients&#xD;
        admitted to hospitalization in the addiction department of the LORIENT Hospital will be&#xD;
        offered participation in the study.&#xD;
  &#xD;
        The primary objective of the study is to determine the prevalence of chronic pain in patients&#xD;
        with substance addiction hospitalized for addiction treatment.&#xD;
  &#xD;
        The study will also evaluate the impact on daily activities of the presence of two chronic&#xD;
        pathologies: chronic pain and addiction, describe the frequency of the two main psychiatric&#xD;
        comorbidities of chronic pain: anxiety and depression, describe the different components of&#xD;
        chronic pain in patients with substance addiction, and get information on analgesic&#xD;
        medications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 10, 2022</start_date>
    <completion_date type="Anticipated">October 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 10, 2024</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>Prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Percentage of patients presenting with pain for more than three months among patients hospitalized in an addiction service for the management of an addiction</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain intensity in the last 24 hours</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Results of the Brief Pain Inventory : worst and least of pain in the last 24 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interference of pain on the quality of life</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Result of Brief pain inventory on general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. On a scale from 0 (does not interfere) to 10 (completely interferes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Localisation of pain</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Drawing on a diagram of a human body</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe the frequency of the two main psychiatric comorbidities of chronic pain: anxiety</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Results of the anxiety scale of Hospital Anxiety and Depression scale. Positive if &gt; 8. Minimum 0, maximum 21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe the frequency of the two main psychiatric comorbidities of chronic pain: depression</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Results of the depression scale of Hospital Anxiety and Depression scale. Positive if &gt; 8. Minimum 0, maximum 21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe the prevalence of fibromyalgia among patients with substance addiction</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Results of the Fibromyalgia Rapid Screening Tool. Suspicion of fibromyalgia if &gt;5 yes. Maximum 6 yes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Information on analgesics medication</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Collection of current analgesic medication taken every day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe the prevalence of neuropathic pain among patients with substance addiction</measure>
      <time_frame>During the hospitalization, maximum 1 month</time_frame>
      <description>Results of the DN3 (neuropathic pain 3). Suspicion of neuropathic pain when &gt; 3/7</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Addiction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients hospitalized in the addictology department of LORIENT Hospital, in full&#xD;
          hospitalization or in a day hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt; 18 years old&#xD;
  &#xD;
            -  Presence of addiction to at least one substance, based on DSM-5 criteria&#xD;
  &#xD;
            -  Hospitalized in the addiction service of LORIENT Hospital&#xD;
  &#xD;
            -  Knowing how to read and write French&#xD;
  &#xD;
            -  Not objecting to their participation in the study after informed information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Already included during a precedent hospitalization&#xD;
  &#xD;
            -  Adults subject to legal protection or deprived of their liberty.&#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>Alexandre Cauchie, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>GH Bretagne Sud</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandre Cauchie, MD</last_name>
      <phone>+ 33 2 97 06 72 90</phone>
      <email>a.cauchie@ghbs.bzh</email>
    </overall_contact>
    <location>
      <facility>
        <name>Groupe Hospitalier Bretagne Sud</name>
        <address>
          <city>Lorient</city>
          <zip>56100</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexandre Cauchie, MD</last_name>
        <phone>02 97 06 72 90</phone>
        <email>a.cauchie@ghbs.bzh</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003 May 14;289(18):2370-8. doi: 10.1001/jama.289.18.2370.</citation>
      <PMID>12746360</PMID>
    </reference>
    <reference>
      <citation>Lusted A, Roerecke M, Goldner E, Rehm J, Fischer B. Prevalence of pain among nonmedical prescription opioid users in substance use treatment populations: systematic review and meta-analyses. Pain Physician. 2013 Nov-Dec;16(6):E671-84.</citation>
      <PMID>24284850</PMID>
    </reference>
    <reference>
      <citation>Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.</citation>
      <PMID>16095934</PMID>
    </reference>
    <reference>
      <citation>Voon P, Greer AM, Amlani A, Newman C, Burmeister C, Buxton JA. Pain as a risk factor for substance use: a qualitative study of people who use drugs in British Columbia, Canada. Harm Reduct J. 2018 Jul 5;15(1):35. doi: 10.1186/s12954-018-0241-y.</citation>
      <PMID>29976203</PMID>
    </reference>
    <reference>
      <citation>Larson MJ, Paasche-Orlow M, Cheng DM, Lloyd-Travaglini C, Saitz R, Samet JH. Persistent pain is associated with substance use after detoxification: a prospective cohort analysis. Addiction. 2007 May;102(5):752-60. doi: 10.1111/j.1360-0443.2007.01759.x.</citation>
      <PMID>17506152</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Groupe Hospitalier de Bretagne Sud</investigator_affiliation>
      <investigator_full_name>Alexandre Cauchie</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Behavior, Addictive</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/NCT05976178
  org study id: 56LORC_2021_ADDICTALGO
  nct id: NCT05976178
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It is described in the literature a higher prevalence of pain in patients with an addiction
        but there are few studies describing the pain profile of patients with use disorder.
  
        Pain has a very negative impact on the quality of life of opioid substituted patients.
        Improving knowledge on this point would make it possible to better guide specific care.
  
        The investigator proposes to conduct a single-center descriptive observational study using
        questionnaires, without changing the management of patients with chronic pain.
  
        The primary objective of the study is to determine the prevalence of chronic pain in patients
        with substance addiction hospitalized for addiction treatment.
  It is described in the literature a higher prevalence of pain in patients with an addiction
        but there are few studies describing the pain profile of patients with use disorder.
  
        Pain has a very negative impact on the quality of life of opioid substituted patients.
        Improving knowledge on this point would make it possible to better guide specific care.
  
        The investigator proposes to conduct a single-center descriptive observational study using
        questionnaires, without changing the management of patients with chronic pain. All patients
        admitted to hospitalization in the addiction department of the LORIENT Hospital will be
        offered participation in the study.
  
        The primary objective of the study is to determine the prevalence of chronic pain in patients
        with substance addiction hospitalized for addiction treatment.
  
        The study will also evaluate the impact on daily activities of the presence of two chronic
        pathologies: chronic pain and addiction, describe the frequency of the two main psychiatric
        comorbidities of chronic pain: anxiety and depression, describe the different components of
        chronic pain in patients with substance addiction, and get information on analgesic
        medications.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.
  time frame: During the hospitalization, maximum 1 month
  description: Percentage of patients presenting with pain for more than three months among patients hospitalized in an addiction service for the management of an addiction
  measure: Pain intensity in the last 24 hours
  time frame: During the hospitalization, maximum 1 month
  description: Results of the Brief Pain Inventory : worst and least of pain in the last 24 hours
  measure: Interference of pain on the quality of life
  time frame: During the hospitalization, maximum 1 month
  description: Result of Brief pain inventory on general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. On a scale from 0 (does not interfere) to 10 (completely interferes)
  measure: Localisation of pain
  time frame: During the hospitalization, maximum 1 month
  description: Drawing on a diagram of a human body
  measure: Describe the frequency of the two main psychiatric comorbidities of chronic pain: anxiety
  time frame: During the hospitalization, maximum 1 month
  description: Results of the anxiety scale of Hospital Anxiety and Depression scale. Positive if > 8. Minimum 0, maximum 21
  measure: Describe the frequency of the two main psychiatric comorbidities of chronic pain: depression
  time frame: During the hospitalization, maximum 1 month
  description: Results of the depression scale of Hospital Anxiety and Depression scale. Positive if > 8. Minimum 0, maximum 21
  measure: Describe the prevalence of fibromyalgia among patients with substance addiction
  time frame: During the hospitalization, maximum 1 month
  description: Results of the Fibromyalgia Rapid Screening Tool. Suspicion of fibromyalgia if >5 yes. Maximum 6 yes
  measure: Information on analgesics medication
  time frame: During the hospitalization, maximum 1 month
  description: Collection of current analgesic medication taken every day
  measure: Describe the prevalence of neuropathic pain among patients with substance addiction
  time frame: During the hospitalization, maximum 1 month
  description: Results of the DN3 (neuropathic pain 3). Suspicion of neuropathic pain when > 3/7
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandre Cauchie, MD
  role: Principal Investigator
  affiliation: GH Bretagne Sud
  last name: Alexandre Cauchie, MD
  phone: + 33 2 97 06 72 90
  email: a.cauchie@ghbs.bzh
  facility: 
  status: Recruiting
  contact: 
  country: France
  citation: Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003 May 14;289(18):2370-8. doi: 10.1001/jama.289.18.2370.
  PMID: 12746360
  citation: Lusted A, Roerecke M, Goldner E, Rehm J, Fischer B. Prevalence of pain among nonmedical prescription opioid users in substance use treatment populations: systematic review and meta-analyses. Pain Physician. 2013 Nov-Dec;16(6):E671-84.
  PMID: 24284850
  citation: Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
  PMID: 16095934
  citation: Voon P, Greer AM, Amlani A, Newman C, Burmeister C, Buxton JA. Pain as a risk factor for substance use: a qualitative study of people who use drugs in British Columbia, Canada. Harm Reduct J. 2018 Jul 5;15(1):35. doi: 10.1186/s12954-018-0241-y.
  PMID: 29976203
  citation: Larson MJ, Paasche-Orlow M, Cheng DM, Lloyd-Travaglini C, Saitz R, Samet JH. Persistent pain is associated with substance use after detoxification: a prospective cohort analysis. Addiction. 2007 May;102(5):752-60. doi: 10.1111/j.1360-0443.2007.01759.x.
  PMID: 17506152
  responsible party type: Principal Investigator
  investigator affiliation: Groupe Hospitalier de Bretagne Sud
  investigator full name: Alexandre Cauchie
  investigator title: Principal Investigator
  mesh term: Chronic Pain
  mesh term: Behavior, Addictive
  sharing ipd: No