Evidence map›Paper›PMID 37256193›Full record

ArticleBrain, behavior, & immunity - health2023

A randomized, placebo-controlled, double-blinded mechanistic clinical trial using endotoxin to evaluate the relationship between insomnia, inflammation, and affective disturbance on pain in older adults: A protocol for the sleep and Healthy Aging Research for pain (SHARE-P) study.

Caitlin M DuPont, Richard Olmstead, Matthew J Reid, Katrina R Hamilton, Claudia M Campbell, Patrick H Finan, Nina Sadeghi, Daisy Castillo, Michael R Irwin, Michael T Smith

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Brain, behavior, & immunity - health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03256760 (Experimental Model of Depression in Aging), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 93% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03256760 phase1completednot on this map

Experimental Model of Depression in Aging: Insomnia, Inflammation, and Affect Mechanisms

TypeinterventionalSponsorMichael Irwin, MDRan2017 to 2024Enrolled160ConditionsDepression in Old AgeArmsEndotoxin, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Caitlin M DuPontDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Richard OlmsteadDepartment of Psychiatry and Biobehavioral Sciences, Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, USA.
Matthew J ReidDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Katrina R HamiltonDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Claudia M CampbellDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Patrick H FinanUniversity of Virginia School of Medicine, Charlottesville, VA, USA.
Nina SadeghiDepartment of Psychiatry and Biobehavioral Sciences, Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, USA.
Daisy CastilloDepartment of Psychiatry and Biobehavioral Sciences, Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, USA.
Michael R IrwinDepartment of Psychiatry and Biobehavioral Sciences, Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, USA.
Michael T SmithDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA.
Johns Hopkins University · USUniversity of California, Los Angeles · USUniversity of Virginia · US

Funding

Interdisciplinary Training in Biobehavioral Pain ResearchT32NS070201 · NINDS · JOHNS HOPKINS UNIVERSITY · PI DONG, XINZHONG, SMITH, MICHAEL T · 2010 to 2024
$3.6M
Experimental model of chronic pain risk: Insomnia, inflammation, central sensitization, and affective disturbanceR01AG057750 · NIA · JOHNS HOPKINS UNIVERSITY · PI SMITH, MICHAEL T · 2018 to 2022
$3.4M
NIA NIH HHS R01 AG057750NINDS NIH HHS T32 NS070201
6 · The paper itself

Abstract

Chronic pain is prevalent in older adults. Treatment, especially with opioids, is often ineffective and poses considerable negative consequences in this population. To improve treatment, it is important to understand why older adults are at a heightened risk for developing chronic pain. Insomnia is a major modifiable risk factor for chronic pain that is ubiquitous among older adults. Insomnia can also lead to heightened systemic inflammation and affective disturbance, both of which may further exacerbate pain conditions in older adults. Endotoxin exposure can be used as an experimental model of systemic inflammation and affective disturbance. The current study aims to understand how insomnia status and endotoxin-induced changes in inflammation and affect (increased negative affect and decreased positive affect) may interact to impact pain facilitatory and inhibitory processes in older adults. Longitudinal data will also assess how pain processing, affective, and inflammatory responses to endotoxin may predict the development of pain and/or depressive symptoms. The current study is a randomized, double-blinded, placebo-controlled, mechanistic clinical trial in men and women, with and without insomnia, aged 50 years and older. Participants were randomized to either 0.8ng/kg endotoxin injection or saline placebo injection. Daily diaries were used to collect variables related to sleep, mood, and pain at two-week intervals during baseline and 3-, 6-, 9-, and 12-months post-injection. Primary outcomes during the experimental phase include conditioned pain modulation, temporal summation, and affective pain modulation ∼5.5 hours after injection. Primary outcomes for longitudinal assessments are self-reported pain intensity and depressive symptoms. The current study uses endotoxin as an experimental model for pain. In doing so, it aims to extend the current literature by: (1) including older adults, (2) investigating insomnia as a potential risk factor for chronic pain, (3) evaluating the role of endotoxin-induced affective disturbances on pain sensitivity, and (4) assessing sex differences in endotoxin-induced hyperalgesia. Clinicaltrialsgov: NCT03256760. Trial sponsor: NIH R01AG057750-01.

Indexed as

EndotoxinInflammationNegative affectPainPositive affect

Identifiers

PMID37256193
PMCPMC10225887
OpenAlexW4377097001

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.