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Inflammation and Daily Life Study

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ClinicalTrials.gov Identifier: NCT03771612
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : April 16, 2019
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, including mental and physical health, and the immune system.

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 4-week period. Participants will also come to the UCLA campus twice for blood draws, to fill out questionnaires, and complete a few tasks on the computer: once prior to the 4-week period and once immediately after the 4-week period.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Inflammation and Daily Life Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

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 6 of study) ]
    Changes in self-report measures of health (using the SF-36)

  2. Sleep [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in sleep (using the Insomnia Severity Index)

  3. Depression [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 6 of study) ]
    Changes in depression (using the Beck Depression Inventory)

  4. 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

  5. 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



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:

  • current smokers
  • active, uncontrolled medical disorders
  • chronic infection (e.g., Hepatitis C, HIV)
  • use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
  • psychiatric disorders (e.g., current major depression, bipolar disorder)
  • body mass index (BMI) greater than 35

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: Mona Moieni, Ph.D. 310-267-5196 ucla.inflammation.study@gmail.com
Contact: Kate Haltom, B.A. uclainflammationstudy@gmail.com

Locations
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United States, California
UCLA Department of Psychology
Los Angeles, California, United States, 90095-1563
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     History of Changes
Other Study ID Numbers: IDL
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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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