Inflammation and Daily Life Study
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|ClinicalTrials.gov Identifier: NCT03771612|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : May 23, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Drug: Naproxen Drug: Placebos||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Inflammation and Daily Life Study|
|Actual Study Start Date :||February 9, 2022|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
|Active Comparator: Naproxen||
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
|Placebo Comparator: Placebo||
Half of the participants will be randomly assigned to receive a placebo pill twice daily
- Self-reported health [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]Changes in self-report measures of health
- Sleep [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]Changes in sleep (using the Insomnia Severity Index)
- Depression [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]Changes in depression (using the Beck Depression Inventory)
- Picture viewing task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]Changes in responses (intensity and valance) of ratings of pictures
- Monetary reward task [ Time Frame: Baseline (Week 1 of study), post-intervention (Week 4 of study) ]Changes in reaction time to potentially winning money in a task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771612
|Contact: Laura Hazlett, M.A.||email@example.com|
|United States, California|
|UCLA Department of Psychology||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Laura I Hazlett, M.A. 949-333-9558 firstname.lastname@example.org|
|Principal Investigator: Naomi Eisenberger, Ph.D.|
|Principal Investigator:||Naomi I Eisenberger, Ph.D.||University of California, Los Angeles|