Trial Outcomes & Findings for Inflammation and Daily Life Study (NCT NCT03771612)
NCT ID: NCT03771612
Last Updated: 2025-02-25
Results Overview
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.
COMPLETED
EARLY_PHASE1
144 participants
T1: Baseline, T2: post-intervention (2 weeks later)
2025-02-25
Participant Flow
Participant milestones
| Measure |
Naproxen
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
79
|
|
Overall Study
COMPLETED
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
24
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation and Daily Life Study
Baseline characteristics by cohort
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 4.94 • n=99 Participants
|
51.9 years
STANDARD_DEVIATION 5.11 • n=107 Participants
|
51.9 years
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Black
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Hispanic/Latino
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · Middle Eastern
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity/Race · White
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
43 participants
n=107 Participants
|
84 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Loneliness
T1 Loneliness
|
47.9 score on a scale
Standard Deviation 10
|
46.9 score on a scale
Standard Deviation 10.5
|
|
Loneliness
T2 Loneliness
|
46.8 score on a scale
Standard Deviation 9.43
|
44.6 score on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Negative Picture Viewing Task
T1 Ratings of Pictures
|
-2.83 score on a scale
Standard Deviation 1.58
|
-2.60 score on a scale
Standard Deviation 1.59
|
|
Negative Picture Viewing Task
T2 Ratings of Pictures
|
-2.90 score on a scale
Standard Deviation 1.61
|
-2.66 score on a scale
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Social Reward Task
T1 RT to close other vs. control
|
-0.012 seconds
Standard Deviation .056
|
-.003 seconds
Standard Deviation .025
|
|
Social Reward Task
T2 RT to close other vs. control
|
-.020 seconds
Standard Deviation .112
|
.002 seconds
Standard Deviation .054
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Inflammatory Gene Expression
T1 Inflammatory Composite
|
.070 logCPM
Standard Deviation .352
|
.057 logCPM
Standard Deviation .357
|
|
Inflammatory Gene Expression
T2 Inflammatory Composite
|
.042 logCPM
Standard Deviation .292
|
.001 logCPM
Standard Deviation .345
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Naproxen
n=41 Participants
Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|
Placebo
n=43 Participants
Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily
|
|---|---|---|
|
Loneliness at Follow-up (2 Weeks Post-intervention)
|
45.1 score on a scale
Standard Deviation 10.7
|
43.5 score on a scale
Standard Deviation 10.8
|
Adverse Events
Naproxen
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place