An Early Phase 1 interventional study of Naproxen and Placebos in Inflammation, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Basic science
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 144 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Following a structured telephone interview, participants with the following conditions will not be able to participate:
Other exclusion criteria may apply.
Drug: Naproxen
Drug: Placebos
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
Half of the participants will be randomly assigned to receive a placebo pill twice daily
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.
Time frame: 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
Time frame: 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
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
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
Time frame: 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.
Time frame: T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)
| Milestone | Naproxen | Placebo |
|---|---|---|
| Started | 65 | 79 |
| Completed | 41 | 43 |
| Not completed | 24 | 36 |
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.
| score on a scale | Naproxen | Placebo |
|---|---|---|
| T1 Loneliness | 47.9 ± 10 | 46.9 ± 10.5 |
| T2 Loneliness | 46.8 ± 9.43 | 44.6 ± 10.5 |
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
| score on a scale | Naproxen | Placebo |
|---|---|---|
| T1 Ratings of Pictures | -2.83 ± 1.58 | -2.60 ± 1.59 |
| T2 Ratings of Pictures | -2.90 ± 1.61 | -2.66 ± 1.51 |
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
| seconds | Naproxen | Placebo |
|---|---|---|
| T1 RT to close other vs. control | -0.012 ± .056 | -.003 ± .025 |
| T2 RT to close other vs. control | -.020 ± .112 | .002 ± .054 |
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
| logCPM | Naproxen | Placebo |
|---|---|---|
| T1 Inflammatory Composite | .070 ± .352 | .057 ± .357 |
| T2 Inflammatory Composite | .042 ± .292 | .001 ± .345 |
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.
| score on a scale | Naproxen | Placebo |
|---|---|---|
| Loneliness at Follow-up (2 Weeks Post-intervention) | 45.1 ± 10.7 | 43.5 ± 10.8 |
Collected over Data were collected while participants were taking naproxen/placebo (2 weeks) as well as in the 2 weeks following the end of the intervention (T1 to T3).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naproxen | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Placebo | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
Baseline includes those subjects who completed the study
| Age, Categorical(Participants) | Naproxen | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 43 | 84 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Naproxen | Placebo | Total |
|---|---|---|---|
| Mean | 51.9 ± 4.94 | 51.9 ± 5.11 | 51.9 ± 5 |
| Sex: Female, Male(Participants) | Naproxen | Placebo | Total |
|---|---|---|---|
| Female | 29 | 31 | 60 |
| Male | 12 | 12 | 24 |
| Race/Ethnicity, Customized(Participants) | Naproxen | Placebo | Total |
|---|---|---|---|
| Ethnicity/Race — Asian | 4 | 3 | 7 |
| Ethnicity/Race — Black | 7 | 5 | 12 |
| Ethnicity/Race — Hispanic/Latino | 11 | 5 | 16 |
| Ethnicity/Race — Middle Eastern | 0 | 2 | 2 |
| Ethnicity/Race — White | 19 | 28 | 47 |
| Region of Enrollment(participants) | Naproxen | Placebo | Total |
|---|---|---|---|
| United States | 41 | 43 | 84 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles