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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG058893-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Gene Expression | Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression | T1: Baseline, T2: post-intervention (2 weeks later) |
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Inclusion Criteria:
Exclusion Criteria: Following a structured telephone interview, participants with the following conditions will not be able to participate:
Other exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Naomi I Eisenberger, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Psychology | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen | Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) |
| FG001 | Placebo | Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline includes those subjects who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen | Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) |
| BG001 | Placebo | Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | T1: Baseline, T2: post-intervention (2 weeks later) |
|
Data were collected while participants were taking naproxen/placebo (2 weeks) as well as in the 2 weeks following the end of the intervention (T1 to T3).
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen | Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Eisenberger | UCLA | 3108494330 | neisenbe@ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2024 | Jan 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebos | Drug | Half of the participants will be randomly assigned to receive a placebo pill twice daily |
|
| Loneliness at Follow-up (2 Weeks Post-intervention) | Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, > 41). Higher values represent higher levels of loneliness. | T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | T1: Baseline, T2: post-intervention (2 weeks later) |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | seconds | T1: Baseline, T2: post-intervention (2 weeks later) |
|
|
|
| Secondary | Inflammatory Gene Expression | Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression | Posted | Mean | Standard Deviation | logCPM | T1: Baseline, T2: post-intervention (2 weeks later) |
|
|
|
| Secondary | Loneliness at Follow-up (2 Weeks Post-intervention) | Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, > 41). Higher values represent higher levels of loneliness. | Posted | Mean | Standard Deviation | score on a scale | T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention) |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Placebo | Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily | 0 | 43 | 0 | 43 | 0 | 43 |
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |