Inflammatory Challenge in Human Aggression.

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.

Conditions

• Intermittent Explosive Disorder

Interventions

BIOLOGICAL

Endotoxin (E. coli O:113, Reference Endotoxin)

Dosage of endotoxin is 0.8 ng/Kg body Weight

OTHER

Saline (Placebo)

Volume of saline to be the same as volume of endotoxin

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Ohio State University

  lead OTHER

Principal Investigators

• Emil F. Coccaro, MD · The Ohio State University College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2029-07-31

Completion

2030-01-31

FDA Drug

Yes

Countries

• United States

Study Locations