Inflammation and Daily Life Study

Study Overview
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Brief Summary
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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 four 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
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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.

Official Title
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Inflammation and Daily Life Study

Conditions
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Inflammation

Intervention / Treatment
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* Drug: Naproxen
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naproxen<br> | Drug: Naproxen<br>* Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Half of the participants will be randomly assigned to receive a placebo pill twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported health | Changes in self-report measures of health | Baseline (Week 1 of study), post-intervention (Week 4 of study) | 
| Sleep | Changes in sleep (using the Insomnia Severity Index) | Baseline (Week 1 of study), post-intervention (Week 4 of study) | 
| Depression | Changes in depression (using the Beck Depression Inventory) | Baseline (Week 1 of study), post-intervention (Week 4 of study) | 
| Picture viewing task | Changes in responses (intensity and valance) of ratings of pictures | Baseline (Week 1 of study), post-intervention (Week 4 of study) | 
| Monetary reward task | Changes in reaction time to potentially winning money in a task | Baseline (Week 1 of study), post-intervention (Week 4 of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune system, Social psychology, Health psychology