Inflammation and Daily Life Study

Early Phase 1

Completed

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Naproxen	Naproxen	-
Placebo	Placebos	-

Primary Outcome Measures

Name	Time	Method
Loneliness	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	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	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 Outcome Measures

Name	Time	Method
Inflammatory Gene Expression	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
Loneliness at Follow-up (2 Weeks Post-intervention)	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.