Inflammation and Daily Life Study

NCT03771612 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: IDL1R21AG058893-01A1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Immune system; Social psychology; Health psychology

Outcome Measures

Primary Outcomes (3)

• Loneliness

  Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness.

  T1: Baseline, T2: post-intervention (2 weeks later)

• Negative Picture Viewing Task

  Changes in ratings of negative pictures "To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive)" Lower scores indicate more negativity

  T1: Baseline, T2: post-intervention (2 weeks later)

• Social Reward Task

  Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images

  T1: Baseline, T2: post-intervention (2 weeks later)

Secondary Outcomes (2)

• Inflammatory Gene Expression

  T1: Baseline, T2: post-intervention (2 weeks later)

• Loneliness at Follow-up (2 Weeks Post-intervention)

  T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)

Study Arms (2)

Naproxen

ACTIVE COMPARATOR

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Naproxen DRUG

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

Naproxen

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults 45-60

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCLA Department of Psychology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Because the study occurred during the COVID pandemic, we had to change our protocol to run all subjects online (drug/placebo was mailed to subjects as were blood collection devices). In addition, due to both budgetary issues and IRB concerns during the COVID pandemic, we had to shorten the planned intervention from 4 to 2 weeks.

Results Point of Contact

• Title: Naomi Eisenberger
• Organization: UCLA

neisenbe@ucla.edu

3108494330

Study Officials

• Naomi I Eisenberger, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 11, 2018
• Study Start: February 9, 2022
• Primary Completion: November 9, 2023
• Study Completion: June 21, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Locations

US (1)