InflammationEarly Phase 1NCT03771612
Inflammation and Daily Life Study
A Early Phase 1 study testing Naproxen in people with Inflammation, run by University of California, Los Angeles at 1 site in United States.
Trial 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 two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 21 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Department of Psychology
Los Angeles, California, 90095
About this 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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Naproxen, Placebos
- Keywords
- Immune system, Social psychology, Health psychology
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
PlacebosDrug
Half of the participants will be randomly assigned to receive a placebo pill twice daily
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
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.
Measured: T1: Baseline, T2: post-intervention (2 weeks later)
Negative Picture Viewing Task
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
Measured: T1: Baseline, T2: post-intervention (2 weeks later)
Social Reward Task
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
Measured: T1: Baseline, T2: post-intervention (2 weeks later)
Secondary outcomes (2)
Inflammatory Gene Expression
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
Measured: T1: Baseline, T2: post-intervention (2 weeks later)
Loneliness at Follow-up (2 Weeks Post-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.
Measured: T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start9 Feb 2022
- Primary completion9 Nov 2023
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Naomi Eisenberger, University of California, Los Angeles
- Investigators
- Naomi I Eisenberger, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771612
- Sponsor's protocol ID
- IDL
- Other IDs
- 1R21AG058893-01A1
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2018
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Daily Life Study
- ClinicalTrials.gov ID
- NCT03771612
- Acronym / sponsor ID
- IDL
- Conditions
- Inflammation
- Keywords
- Immune system, Social psychology, Health psychology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Active comparator | Drug: Naproxen |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaproxenHalf of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) | Drug | Naproxen |
| PlacebosHalf of the participants will be randomly assigned to receive a placebo pill twice daily | Drug | Placebo |
Primary outcome
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.
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
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
2 secondary outcomes
Inflammatory Gene Expression
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi I Eisenberger, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Naproxen in people with Inflammation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: T1: Baseline, T2: post-intervention (2 weeks later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.