Clinical trial NCT03771612: Inflammation and Daily Life Study
Official title: Inflammation and Daily Life Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Inflammation
Keywords: Immune system
Social psychology
Health psychology
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-12-11
Enrollment: 144
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 two 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Loneliness
timeFrame: T1: Baseline, T2: post-intervention (2 weeks later)
measure: Negative Picture Viewing Task
timeFrame: T1: Baseline, T2: post-intervention (2 weeks later)
measure: Social Reward Task
timeFrame: T1: Baseline, T2: post-intervention (2 weeks later)
Secondary outcomes:
measure: Inflammatory Gene Expression
timeFrame: T1: Baseline, T2: post-intervention (2 weeks later)
measure: Loneliness at Follow-up (2 Weeks Post-intervention)
timeFrame: T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Psychology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Naomi I Eisenberger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: