<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/NCT03771612</url>
  </required_header>
  <id_info>
    <org_study_id>IDL</org_study_id>
    <nct_id>NCT03771612</nct_id>
  </id_info>
  <brief_title>Inflammation and Daily Life Study</brief_title>
  <official_title>Inflammation and Daily Life Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      UCLA researchers looking for healthy individuals (age 45-60) to participate in a study&#xD;
      investigating whether an anti-inflammatory medication can impact daily life experiences.&#xD;
&#xD;
      Everyday for four weeks, participants will take either an anti-inflammatory medication&#xD;
      (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily&#xD;
      questions during the 2-week period. Participants will also fill out questionnaires and&#xD;
      complete a few tasks on the computer: once prior to the 2-week period and once immediately&#xD;
      after the 2-week period, both during online study sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will&#xD;
      first complete a structured telephone interview in order to assess eligibility.&#xD;
&#xD;
      The study will begin with filling out questionnaires, as well as an online session to&#xD;
      complete some tasks. You will then be randomly assigned to take either an anti-inflammatory&#xD;
      medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the&#xD;
      following two weeks. You will also be contacted by text message to remind you to take your&#xD;
      pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires&#xD;
      once daily. After the two weeks are over, you will again complete questionnaires and the&#xD;
      online study session with tasks. Finally, two weeks after the second session, you will&#xD;
      receive an email to fill out questionnaires online.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2022</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported health</measure>
    <time_frame>Baseline (Week 1 of study), post-intervention (Week 4 of study)</time_frame>
    <description>Changes in self-report measures of health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep</measure>
    <time_frame>Baseline (Week 1 of study), post-intervention (Week 4 of study)</time_frame>
    <description>Changes in sleep (using the Insomnia Severity Index)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline (Week 1 of study), post-intervention (Week 4 of study)</time_frame>
    <description>Changes in depression (using the Beck Depression Inventory)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Picture viewing task</measure>
    <time_frame>Baseline (Week 1 of study), post-intervention (Week 4 of study)</time_frame>
    <description>Changes in responses (intensity and valance) of ratings of pictures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monetary reward task</measure>
    <time_frame>Baseline (Week 1 of study), post-intervention (Week 4 of study)</time_frame>
    <description>Changes in reaction time to potentially winning money in a task</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Naproxen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen</intervention_name>
    <description>Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)</description>
    <arm_group_label>Naproxen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Half of the participants will be randomly assigned to receive a placebo pill twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults 45-60&#xD;
&#xD;
        Exclusion Criteria: Following a structured telephone interview, participants with the&#xD;
        following conditions will not be able to participate:&#xD;
&#xD;
          -  certain active, uncontrolled medical disorders&#xD;
&#xD;
          -  use of certain medications (e.g., hypnotic and psychotropic medication, steroid use,&#xD;
             opioid use)&#xD;
&#xD;
          -  psychiatric disorders (e.g., current major depression, bipolar disorder)&#xD;
&#xD;
        Other exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi I Eisenberger, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Hazlett, M.A.</last_name>
    <phone>949-333-9558</phone>
    <email>ucla.inflammation.study@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UCLA Department of Psychology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura I Hazlett, M.A.</last_name>
      <phone>949-333-9558</phone>
      <email>ucla.inflammation.study@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Naomi Eisenberger, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Naomi Eisenberger</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Immune system</keyword>
  <keyword>Social psychology</keyword>
  <keyword>Health psychology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
  </intervention_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/NCT03771612
org study id: IDL
nct id: NCT03771612
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
UCLA researchers looking for healthy individuals (age 45-60) to participate in a study
      investigating whether an anti-inflammatory medication can impact daily life experiences.

      Everyday for four weeks, participants will take either an anti-inflammatory medication
      (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily
      questions during the 2-week period. Participants will also fill out questionnaires and
      complete a few tasks on the computer: once prior to the 2-week period and once immediately
      after the 2-week period, both during online study sessions.
Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will
      first complete a structured telephone interview in order to assess eligibility.

      The study will begin with filling out questionnaires, as well as an online session to
      complete some tasks. You will then be randomly assigned to take either an anti-inflammatory
      medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the
      following two weeks. You will also be contacted by text message to remind you to take your
      pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires
      once daily. After the two weeks are over, you will again complete questionnaires and the
      online study session with tasks. Finally, two weeks after the second session, you will
      receive an email to fill out questionnaires online.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Self-reported health
time frame: Baseline (Week 1 of study), post-intervention (Week 4 of study)
description: Changes in self-report measures of health
measure: Sleep
time frame: Baseline (Week 1 of study), post-intervention (Week 4 of study)
description: Changes in sleep (using the Insomnia Severity Index)
measure: Depression
time frame: Baseline (Week 1 of study), post-intervention (Week 4 of study)
description: Changes in depression (using the Beck Depression Inventory)
measure: Picture viewing task
time frame: Baseline (Week 1 of study), post-intervention (Week 4 of study)
description: Changes in responses (intensity and valance) of ratings of pictures
measure: Monetary reward task
time frame: Baseline (Week 1 of study), post-intervention (Week 4 of study)
description: Changes in reaction time to potentially winning money in a task
arm group label: Naproxen
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Naproxen
description: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
arm group label: Naproxen
intervention type: Drug
intervention name: Placebos
description: Half of the participants will be randomly assigned to receive a placebo pill twice daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi I Eisenberger, Ph.D.
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Laura Hazlett, M.A.
phone: 949-333-9558
email: ucla.inflammation.study@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Naomi Eisenberger
investigator title: Professor
mesh term: Inflammation
mesh term: Naproxen