<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/NCT03036917</url>
  </required_header>
  <id_info>
    <org_study_id>SE-4-2016</org_study_id>
    <nct_id>NCT03036917</nct_id>
  </id_info>
  <brief_title>Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain</brief_title>
  <acronym>coffee-cup</acronym>
  <official_title>Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the cognitive function of patients in the opioid reduction&#xD;
      programme at the multidisciplinary pain centre at Zealand University Hospital Køge.&#xD;
&#xD;
      The patients will be tested before, halfway through, and after the programme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of patients with chronic non-malignant pain is high and constant. An estimated&#xD;
      3-5% of the population use opioids daily. These patients have a lower quality of life and a&#xD;
      higher use of healthcare services.&#xD;
&#xD;
      This leads to enormous costs, both human and economic. Many patients lose their ability to&#xD;
      work, not only because of the pain, but also because of their treatment.&#xD;
&#xD;
      For a long period, opioids have been prescribed for chronic pain, even though the evidence is&#xD;
      scarce.&#xD;
&#xD;
      A rising conscience about opioid use is on the way, and now, there is a tendency to reduce,&#xD;
      rather than increase opioids.&#xD;
&#xD;
      The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief&#xD;
      of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may&#xD;
      even lead to higher levels of pain.&#xD;
&#xD;
      Many patients are at first reluctant to start the reduction programme. Mostly because the&#xD;
      patients may not be aware of the effects, the drugs are having on them. Many patients value&#xD;
      their opioid treatment as positive and necessary, in spite of the many adverse effects.&#xD;
&#xD;
      The investigators wanted to test the cognitive function of patients before, during and after&#xD;
      opioid reduction. The results can be used to help patients understand the deleterious effects&#xD;
      of high opioid usage, and can also be used to motivate the individual patient along the way.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</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>Cognitive function before opioid reduction</measure>
    <time_frame>At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive function at halfway point</measure>
    <time_frame>When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)</time_frame>
    <description>Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function at end of reduction</measure>
    <time_frame>When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function before opioid reduction</measure>
    <time_frame>At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Executive function measured by Trail making test A and B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function at halfway point</measure>
    <time_frame>When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)</time_frame>
    <description>Executive function measured by Trail making test A and B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function at end of reduction</measure>
    <time_frame>When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Executive function measured by Trail making test A and B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine use before reduction</measure>
    <time_frame>At first visit to pain clinic (Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Morphine equivalents before reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine use after reduction</measure>
    <time_frame>At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Morphine equivalents after reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of other analgesics before reduction</measure>
    <time_frame>At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Use of any other analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of other analgesics at halfway point</measure>
    <time_frame>When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)</time_frame>
    <description>Use of any other analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of other analgesics after reduction</measure>
    <time_frame>At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Use of any other analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life before reduction</measure>
    <time_frame>At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Quality of life measured by SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life at halfway point</measure>
    <time_frame>When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)</time_frame>
    <description>Quality of life measured by SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life at end of reduction</measure>
    <time_frame>At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Quality of life measured by SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of anxiety and depression before reduction</measure>
    <time_frame>At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)</time_frame>
    <description>Risk of anxiety and depression measured by Hospital anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of anxiety and depression at halfway point</measure>
    <time_frame>When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)</time_frame>
    <description>Risk of anxiety and depression measured by Hospital anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of anxiety and depression at end of reduction</measure>
    <time_frame>At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)</time_frame>
    <description>Risk of anxiety and depression measured by Hospital anxiety and depression scale</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Nonmalignant Pain</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Opiate Dependence</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic pain, treated with opioids and participating in the opioid reduction&#xD;
        programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age and able to provide a written consent&#xD;
&#xD;
          -  Participating in the opioid reduction programme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to speak and understand Danish&#xD;
&#xD;
          -  Patients suffering from dementia or psychosis&#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>Stine Estrup, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zealand University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holbæk Hospital</name>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <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>


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/NCT03036917
org study id: SE-4-2016
nct id: NCT03036917
lead sponsor: 
has dmc: Yes
This study aims to investigate the cognitive function of patients in the opioid reduction
      programme at the multidisciplinary pain centre at Zealand University Hospital Køge.

      The patients will be tested before, halfway through, and after the programme.
The number of patients with chronic non-malignant pain is high and constant. An estimated
      3-5% of the population use opioids daily. These patients have a lower quality of life and a
      higher use of healthcare services.

      This leads to enormous costs, both human and economic. Many patients lose their ability to
      work, not only because of the pain, but also because of their treatment.

      For a long period, opioids have been prescribed for chronic pain, even though the evidence is
      scarce.

      A rising conscience about opioid use is on the way, and now, there is a tendency to reduce,
      rather than increase opioids.

      The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief
      of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may
      even lead to higher levels of pain.

      Many patients are at first reluctant to start the reduction programme. Mostly because the
      patients may not be aware of the effects, the drugs are having on them. Many patients value
      their opioid treatment as positive and necessary, in spite of the many adverse effects.

      The investigators wanted to test the cognitive function of patients before, during and after
      opioid reduction. The results can be used to help patients understand the deleterious effects
      of high opioid usage, and can also be used to motivate the individual patient along the way.
observational model: Cohort
time perspective: Prospective
measure: Cognitive function before opioid reduction
time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
description: Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
measure: Cognitive function at halfway point
time frame: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
description: Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
measure: Cognitive function at end of reduction
time frame: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
measure: Executive function before opioid reduction
time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
description: Executive function measured by Trail making test A and B
measure: Executive function at halfway point
time frame: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
description: Executive function measured by Trail making test A and B
measure: Executive function at end of reduction
time frame: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Executive function measured by Trail making test A and B
measure: Morphine use before reduction
time frame: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
description: Morphine equivalents before reduction
measure: Morphine use after reduction
time frame: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Morphine equivalents after reduction
measure: Use of other analgesics before reduction
time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
description: Use of any other analgesic
measure: Use of other analgesics at halfway point
time frame: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
description: Use of any other analgesic
measure: Use of other analgesics after reduction
time frame: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Use of any other analgesic
measure: Quality of life before reduction
time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
description: Quality of life measured by SF36
measure: Quality of life at halfway point
time frame: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
description: Quality of life measured by SF36
measure: Quality of life at end of reduction
time frame: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Quality of life measured by SF36
measure: Risk of anxiety and depression before reduction
time frame: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
description: Risk of anxiety and depression measured by Hospital anxiety and depression scale
measure: Risk of anxiety and depression at halfway point
time frame: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
description: Risk of anxiety and depression measured by Hospital anxiety and depression scale
measure: Risk of anxiety and depression at end of reduction
time frame: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
description: Risk of anxiety and depression measured by Hospital anxiety and depression scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stine Estrup, MD
role: Principal Investigator
affiliation: Zealand University Hospital
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Opioid-Related Disorders
sharing ipd: No