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NCT06665074 · ClinicalTrials.gov registry record · Phase 2
Inflammatory Challenge in Human Aggression.
A Phase 2 study, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT06665074 is a Phase 2 study that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 112 participants.
The verdict
NCT06665074, a Phase 2 study, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to explore the differences in behavioral and cytokine response to a low dose infusion of endotoxin (vs. placebo) in individuals with histories of frequent, problematic, impulsive aggression ("aggressives") compared to similar individuals without this history ("controls"). Endotoxin is a substance that produces a reliable inflammation response in human subjects. The main questions it aims to answer are: * Do aggressive individuals have greater self-rated anger responses to low-dose endotoxin compared with controls? * Do aggressive individuals have greater analog aggressive responses (in the Taylor Aggression Paradigm) to low-dose endotoxin compared with controls? * Do aggressive individuals have greater hostile attributional and negative emotional responses (in the V-SEIP) to low-dose endotoxin compared with controls? * Do aggressive individuals have greater plasma pro-inflammatory responses to low-dose endotoxin compared with controls? * Do aggressive individuals display a greater activation of brain responses to anger-related picture during an MRI scan during low-dose endotoxin compared with controls? Researchers will compare endotoxin to a placebo (a look-alike substance that contains no drug) explore the differences in behavioral and cytokine response to a low dose infusion of endotoxin (vs. placebo) in individuals with histories of frequent, problematic, impulsive aggression ("aggressives") compared to similar individuals without this history ("controls"). Participants will: * Receive a low-dose of endotoxin and placebo on two (2) separate days. The study drugs will be given through a plastic tube inserted in a forearm vein. * Visit the laboratory on at least two (2) separate days to receive the endotoxin and placebo. * Complete rating forms, behavioral testing, and an MRI on each of the two (2) laboratory days.
Interventions
- BIOLOGICAL Endotoxin (E. coli O:113, Reference Endotoxin)
- OTHER Saline (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2026-02-16 |
| Est. Completion | 2030-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06665074
The ClinicalTrials.gov registry entry for NCT06665074 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Endotoxin (E. coli O:113, Reference Endotoxin) is the first listed.
NCT06665074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06665074 about?
NCT06665074 is a clinical study titled "Inflammatory Challenge in Human Aggression.". The goal of this clinical trial is to explore the differences in behavioral and cytokine response to a low dose infusion of endotoxin (vs. placebo) in individuals with histories of frequent, problematic, impulsive aggression ("aggressives") compared to similar individuals without this history ("cont...
What is the current status of trial NCT06665074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2026-02-16. Estimated completion is 2030-01.
What interventions are being tested in trial NCT06665074?
The interventions under investigation include: Endotoxin (E. coli O:113, Reference Endotoxin) (BIOLOGICAL), Saline (Placebo) (OTHER).
Who is sponsoring clinical trial NCT06665074?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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