Inflammation and Daily Life Study

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT03771612

Collaborator

(none)

Enrollment

Location

Arms

10.7

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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 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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Inflammation and Daily Life Study

Actual Study Start Date :

Feb 9, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naproxen	Drug: 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	Drug: Placebos Half of the participants will be randomly assigned to receive a placebo pill twice daily

Arm

Intervention/Treatment

Active Comparator: Naproxen

Drug: 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

Drug: Placebos

Half of the participants will be randomly assigned to receive a placebo pill twice daily

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Department of Psychology	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator: Naomi I Eisenberger, Ph.D., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naomi Eisenberger, Professor, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT03771612

Other Study ID Numbers:

First Posted:

Dec 11, 2018

Last Update Posted:

May 23, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Naomi Eisenberger, Professor, University of California, Los Angeles

Immune system

Social psychology

Health psychology

Additional relevant MeSH terms:

Inflammation

Naproxen

Study Results

No Results Posted as of May 23, 2022