Inflammation and Daily Life Study

Inflammation Clinical Trial

Official title:

Inflammation and Daily Life Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771612
• Other study ID #: IDL
• Secondary ID: 1R21AG058893-01A
• Status: Completed
• Phase: Early Phase 1
• Start date: February 9, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Naproxen
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
• Placebos
Half of the participants will be randomly assigned to receive a placebo pill twice daily

Locations

Country	Name	City	State
United States	UCLA Department of Psychology	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported health	Changes in self-report measures of health	Baseline (Week 1 of study), post-intervention (Week 4 of study)
Primary	Sleep	Changes in sleep (using the Insomnia Severity Index)	Baseline (Week 1 of study), post-intervention (Week 4 of study)
Primary	Depression	Changes in depression (using the Beck Depression Inventory)	Baseline (Week 1 of study), post-intervention (Week 4 of study)
Primary	Picture viewing task	Changes in responses (intensity and valance) of ratings of pictures	Baseline (Week 1 of study), post-intervention (Week 4 of study)
Primary	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)