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Inflammation and Daily Life Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771612
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Naomi Eisenberger, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date May 23, 2022
Actual Study Start Date  ICMJE February 9, 2022
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • Self-reported health [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in self-report measures of health
  • Sleep [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in sleep (using the Insomnia Severity Index)
  • Depression [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in depression (using the Beck Depression Inventory)
  • Picture viewing task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in responses (intensity and valance) of ratings of pictures
  • Monetary reward task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in reaction time to potentially winning money in a task
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Self-reported health [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in self-report measures of health (using the SF-36)
  • Sleep [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in sleep (using the Insomnia Severity Index)
  • Depression [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in depression (using the Beck Depression Inventory)
  • Picture viewing task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in responses (intensity and valance) of ratings of pictures
  • Monetary reward task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in reaction time to potentially winning money in a task
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammation and Daily Life Study
Official Title  ICMJE Inflammation and Daily Life Study
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Inflammation
Intervention  ICMJE
  • Drug: Naproxen
    Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
  • Drug: Placebos
    Half of the participants will be randomly assigned to receive a placebo pill twice daily
Study Arms  ICMJE
  • Active Comparator: Naproxen
    Intervention: Drug: Naproxen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2021)
50
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
100
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy adults 45-60

Exclusion Criteria: Following a structured telephone interview, participants with the following conditions will not be able to participate:

  • certain active, uncontrolled medical disorders
  • use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
  • psychiatric disorders (e.g., current major depression, bipolar disorder)

Other exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Laura Hazlett, M.A. 949-333-9558 ucla.inflammation.study@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03771612
Other Study ID Numbers  ICMJE IDL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Naomi Eisenberger, University of California, Los Angeles
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naomi I Eisenberger, Ph.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP