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Inflammation and Daily Life Study

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Completed
Early Phase 1

Conditions

Inflammation

Treatments

Drug: Placebos
Drug: Naproxen

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03771612
IDL
1R21AG058893-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

All

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

144 participants in 2 patient groups, including a placebo group

Naproxen
Active Comparator group
Treatment:
Drug: Naproxen
Placebo
Placebo Comparator group
Treatment:
Drug: Placebos

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Laura Hazlett, M.A.

Data sourced from clinicaltrials.gov

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