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Inflammation and Daily Life Study

Primary Purpose

Inflammation

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Naproxen

Placebos

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Immune system, Social psychology, Health psychology

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UCLA Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naproxen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Self-reported health

Changes in self-report measures of health

Sleep

Changes in sleep (using the Insomnia Severity Index)

Depression

Changes in depression (using the Beck Depression Inventory)

Picture viewing task

Changes in responses (intensity and valance) of ratings of pictures

Monetary reward task

Changes in reaction time to potentially winning money in a task

Secondary Outcome Measures

Full Information

NCT ID

NCT03771612

First Posted

December 6, 2018

Last Updated

September 20, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03771612

Brief Title

Inflammation and Daily Life Study

Official Title

Inflammation and Daily Life Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 9, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

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.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation

Keywords

Immune system, Social psychology, Health psychology

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naproxen

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Naproxen

Intervention Description

Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

Self-reported health

Description

Changes in self-report measures of health

Time Frame