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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

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.


Condition or disease Intervention/treatment Phase
Inflammation Drug: Naproxen Drug: Placebos Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Inflammation and Daily Life Study
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Naproxen Drug: Naproxen
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)

Placebo Comparator: Placebo Drug: Placebos
Half of the participants will be randomly assigned to receive a placebo pill twice daily




Primary Outcome Measures :
  1. Self-reported health [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in self-report measures of health

  2. Sleep [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in sleep (using the Insomnia Severity Index)

  3. Depression [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]
    Changes in depression (using the Beck Depression Inventory)

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771612


Contacts
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Contact: Laura Hazlett, M.A. 949-333-9558 ucla.inflammation.study@gmail.com

Locations
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United States, California
UCLA Department of Psychology Recruiting
Los Angeles, California, United States, 90095
Contact: Laura I Hazlett, M.A.    949-333-9558    ucla.inflammation.study@gmail.com   
Principal Investigator: Naomi Eisenberger, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Naomi I Eisenberger, Ph.D. University of California, Los Angeles
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Responsible Party: Naomi Eisenberger, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03771612    
Other Study ID Numbers: IDL
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: January 2022

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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
Keywords provided by Naomi Eisenberger, University of California, Los Angeles:
Immune system
Social psychology
Health psychology
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action