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Completed

NCT Number: NCT03771612

Inflammation and Daily Life Study

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 two 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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA Department of Psychology

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)

Placebos

Drug

Half of the participants will be randomly assigned to receive a placebo pill twice daily

Primary outcomes

  1. Loneliness

    Time frame: T1: Baseline, T2: post-intervention (2 weeks later)

    Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, > 41). Higher values represent higher levels of loneliness.

  2. Negative Picture Viewing Task

    Time frame: T1: Baseline, T2: post-intervention (2 weeks later)

    Changes in ratings of negative pictures "To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive)" Lower scores indicate more negativity

  3. Social Reward Task

    Time frame: T1: Baseline, T2: post-intervention (2 weeks later)

    Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images

Secondary outcomes

  1. Inflammatory Gene Expression

    Time frame: T1: Baseline, T2: post-intervention (2 weeks later)

    Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression

  2. Loneliness at Follow-up (2 Weeks Post-intervention)

    Time frame: T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)

    Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, > 41). Higher values represent higher levels of loneliness.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 11, 2018
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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