<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/NCT03248765</url>
  </required_header>
  <id_info>
    <org_study_id>201707017</org_study_id>
    <nct_id>NCT03248765</nct_id>
  </id_info>
  <brief_title>Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use</brief_title>
  <official_title>Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
      The purpose of this study is to determine if the research results obtained in animal models&#xD;
      of pain - that show that being in pain for some time increases opioid use beyond what is&#xD;
      expected to treat the current pain - also apply to patients with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of chronic pain is very high in the US at approximately 30%. More than 10% of&#xD;
      adults report having daily pain. Opioid pain medications [such as morphine] are prescribed&#xD;
      for some pain conditions and, since they are very addictive, they can be used inappropriately&#xD;
      and abused, to the point of causing overdose and death. This is currently a significant&#xD;
      problem in the US and worldwide. Research on changes in the brain that cause addiction in&#xD;
      pain patients is complicated, also because it is difficult to separate the effect of the&#xD;
      drugs that cause addiction from the direct effect of pain on the brain. Studies in animals&#xD;
      have found that pain per se can change the brain in ways that increase the risk of becoming&#xD;
      addicted to pain medications. Therefore, we think that patients who have chronic pain and are&#xD;
      prescribed opioid pain medications to treat surgery-related pain after surgery, although they&#xD;
      never took opioids for a long time in their life, may be at increased risk of using too much&#xD;
      opioid medications, and using opioids for a longer time than expected to treat their surgical&#xD;
      pain.&#xD;
&#xD;
      The purpose of this study is to determine if the research results obtained in animal models&#xD;
      of pain (that show that being in pain for some time increases opioid use beyond what is&#xD;
      expected to treat the current pain) also apply to patients with chronic pain.&#xD;
&#xD;
      For our study we are looking to recruit patients scheduled for abdominal surgery at Barnes&#xD;
      Jewish Hospital. If eligible and enrolled, subjects will undergo sensory testing (a test of&#xD;
      the sensitivity of the skin to hot and cold temperature and pressure) and complete&#xD;
      questionnaires about their experience with pain, anxiety, depression and risk of substance&#xD;
      abuse. They will also have a one-time blood draw for genetic testing, to look for a&#xD;
      particular gene that is potentially associated with how we respond to pain medications and,&#xD;
      potentially, with increased risk for addiction. After the surgery, patients will be assessed&#xD;
      by the research team on day 1, week 1, week 4, week 8, and after 6 months with similar&#xD;
      questionnaires to those that were completed pre-surgery. Patient satisfaction with their&#xD;
      pre-surgical and post-surgical pain control will also be assessed by questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient patient enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">September 11, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 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>Post-surgical opioid use</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>oral morphine equivalents (mg/day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-surgical opioid use</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>oral morphine equivalents (mg/day)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Chronic pain group</arm_group_label>
    <description>post-surgical opioid use measured at 1 day and 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No chronic pain</arm_group_label>
    <description>post-surgical opioid use measured at 1 day and 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>post-surgical opioid use measured at 1 day and 1 week.</intervention_name>
    <description>Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).&#xD;
2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ).</description>
    <arm_group_label>Chronic pain group</arm_group_label>
    <arm_group_label>No chronic pain</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Genotype analysis will be performed to control for A118G single nucleotide polymorphism&#xD;
      (SNP).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with and without chronic musculoskeletal pain or osteoarthritis pain that are&#xD;
        having planned non-cancer related surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-65&#xD;
&#xD;
          2. With and without history of chronic muscle-skeletal pain *&#xD;
&#xD;
          3. Scheduled to undergo elective abdominal surgery requiring overnight hospital admission&#xD;
&#xD;
          4. Opioid naïve**&#xD;
&#xD;
          5. Willing to comply with study procedures as outlined in the protocol&#xD;
&#xD;
          6. Willing and able to provide informed consent&#xD;
&#xD;
          7. Having an email address and access to a computer or electronic tablet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current use of opioids (includes ANY use in past 3 months)&#xD;
&#xD;
          2. Cancer diagnosis&#xD;
&#xD;
          3. Patient presenting the following documented conditions:&#xD;
&#xD;
        Untreated psychosis Current suicidal ideation Current substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Laura Cavallone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University in St Louis School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>October 9, 2020</last_update_submitted>
  <last_update_submitted_qc>October 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</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>
  </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>
  </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/NCT03248765
org study id: 201707017
nct id: NCT03248765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if the research results obtained in animal models
      of pain - that show that being in pain for some time increases opioid use beyond what is
      expected to treat the current pain - also apply to patients with chronic pain.
The prevalence of chronic pain is very high in the US at approximately 30%. More than 10% of
      adults report having daily pain. Opioid pain medications [such as morphine] are prescribed
      for some pain conditions and, since they are very addictive, they can be used inappropriately
      and abused, to the point of causing overdose and death. This is currently a significant
      problem in the US and worldwide. Research on changes in the brain that cause addiction in
      pain patients is complicated, also because it is difficult to separate the effect of the
      drugs that cause addiction from the direct effect of pain on the brain. Studies in animals
      have found that pain per se can change the brain in ways that increase the risk of becoming
      addicted to pain medications. Therefore, we think that patients who have chronic pain and are
      prescribed opioid pain medications to treat surgery-related pain after surgery, although they
      never took opioids for a long time in their life, may be at increased risk of using too much
      opioid medications, and using opioids for a longer time than expected to treat their surgical
      pain.

      The purpose of this study is to determine if the research results obtained in animal models
      of pain (that show that being in pain for some time increases opioid use beyond what is
      expected to treat the current pain) also apply to patients with chronic pain.

      For our study we are looking to recruit patients scheduled for abdominal surgery at Barnes
      Jewish Hospital. If eligible and enrolled, subjects will undergo sensory testing (a test of
      the sensitivity of the skin to hot and cold temperature and pressure) and complete
      questionnaires about their experience with pain, anxiety, depression and risk of substance
      abuse. They will also have a one-time blood draw for genetic testing, to look for a
      particular gene that is potentially associated with how we respond to pain medications and,
      potentially, with increased risk for addiction. After the surgery, patients will be assessed
      by the research team on day 1, week 1, week 4, week 8, and after 6 months with similar
      questionnaires to those that were completed pre-surgery. Patient satisfaction with their
      pre-surgical and post-surgical pain control will also be assessed by questionnaire.
observational model: Case-Control
time perspective: Prospective
measure: Post-surgical opioid use
time frame: 24 hours post-operatively
description: oral morphine equivalents (mg/day)
measure: Post-surgical opioid use
time frame: 1 week post-operatively
description: oral morphine equivalents (mg/day)
arm group label: Chronic pain group
description: post-surgical opioid use measured at 1 day and 1 week.
arm group label: No chronic pain
description: post-surgical opioid use measured at 1 day and 1 week.
intervention type: Other
intervention name: post-surgical opioid use measured at 1 day and 1 week.
description: Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).
2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ).
arm group label: Chronic pain group
arm group label: No chronic pain
Genotype analysis will be performed to control for A118G single nucleotide polymorphism
      (SNP).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Laura Cavallone, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Analgesics, Opioid
sharing ipd: Undecided