<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/NCT03781570</url>
  </required_header>
  <id_info>
    <org_study_id>Pain Genetics</org_study_id>
    <nct_id>NCT03781570</nct_id>
  </id_info>
  <brief_title>Brain and Genetic Predictors of Individual Differences in Pain and Analgesia</brief_title>
  <acronym>PAINGEN</acronym>
  <official_title>Brain and Genetic Predictors of Individual Differences in Pain and Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>QIMR Berghofer Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Boulder</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 the study is to gain a better understanding of pain processing in the brain.&#xD;
      Our understanding of how pain is processed in the brain is limited. We are testing for&#xD;
      individual differences in pain perception and emotion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Anticipated">November 7, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 7, 2022</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>Change in pain rating scores made on a Visual Analog Scale (VAS)</measure>
    <time_frame>Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).</time_frame>
    <description>Self reported pain using the VAS ranging from 0-100 (with 0 representing &quot;no pain at all&quot; and 100 representing &quot;most intense pain imaginable (in the context of the experiment)).</description>
  </primary_outcome>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Pain, Acute</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will collect saliva samples during the fMRI scan day and genotype using the same facility&#xD;
      (same laboratory, personnel, platform, and protocols), following standard GWAS quality&#xD;
      control procedures.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The CTS includes 727 same-sex twin pairs between 26-38 years old (as of Spring 2017),&#xD;
        originally derived from the Colorado Twin Registry, a population based registry, housed at&#xD;
        the Institute for Behavioral Genetics (IBG) at the University of Colorado since 1984, with&#xD;
        three previous waves of data collection (1997-2002, 2002-2008, and 2009-2014).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be registered in the Colorado Community Twin Sample (CTS).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not being registered in the Colorado Community Twin Sample (CTS).&#xD;
&#xD;
          -  Any MRI contraindications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tor Wager, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado, Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Tor Wager</investigator_full_name>
    <investigator_title>Director, Cognitive and Affective Neuroscience Laboratory; Professor, Department of Psychology and Neuroscience and the Institute for Cognitive Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03781570
org study id: Pain Genetics
nct id: NCT03781570
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to gain a better understanding of pain processing in the brain.
      Our understanding of how pain is processed in the brain is limited. We are testing for
      individual differences in pain perception and emotion.
observational model: Cohort
time perspective: Prospective
measure: Change in pain rating scores made on a Visual Analog Scale (VAS)
time frame: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).
description: Self reported pain using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
We will collect saliva samples during the fMRI scan day and genotype using the same facility
      (same laboratory, personnel, platform, and protocols), following standard GWAS quality
      control procedures.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
last name: Tor Wager, PHD
role: Principal Investigator
affiliation: University of Colorado, Boulder
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Tor Wager
investigator title: Director, Cognitive and Affective Neuroscience Laboratory; Professor, Department of Psychology and Neuroscience and the Institute for Cognitive Science
mesh term: Acute Pain