Early Phase 1
N=144
Inflammation and Daily Life Study
Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03771612 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Loneliness — 47.9; 46.9; 46.8; 44.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Naproxen (Drug); Placebos (Drug)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Loneliness |
47.9; 46.9; 46.8; 44.6 | — |
| PRIMARY Negative Picture Viewing Task |
-2.83; -2.60; -2.90; -2.66 | — |
| PRIMARY Social Reward Task |
-0.012; -.003; -.020; .002 | — |
| SECONDARY Inflammatory Gene Expression |
.070; .057; .042; .001 | — |
| SECONDARY Loneliness at Follow-up (2 Weeks Post-intervention) |
45.1; 43.5 | — |
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. 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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03771612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.