NCT06665074 Inflammatory Challenge in Human Aggression.
| NCT ID | NCT06665074 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ohio State University |
| Condition | Intermittent Explosive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2026-02-16 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: "Aggressive Subjects" will have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and have a Life History of Aggression (LHA) \> 12. "Control Subjects" will not have current or past history of IED and will have LHA scores \< 11 ("Control Subjects" may have a past, but not current, history of Major Depression (MD), Generalized Anxiety Disorder (GAD), Panic Disorder (PDx), or Post-Traumatic Stress (PTSD) Disorder. Participant is between 21 and 55 years of age and is able to give informed consent. Participant is physically healthy as confirmed by medical history, physical evaluation, and (in females) a negative pregnancy test. Exclusion Criteria: Participants with a current clinically significant medical condition. Participants current co-morbid Major Depression (MD), Generalized Anxiety Disorder (GAD), Panic Disorder (PDx), or Post-Traumatic Stress (PTSD) Disorder. Participants currently taking prescribed medications for an active medical or psychiatric condition. Participants not free of prescribed medications for four weeks. Participants with Grade 2 or higher abnormalities on clinical laboratory examination (e.g., CBC with Differential, Metabolic Panel, and PT/INR/PTTa). Participants with Bradycardia (i.e., heart rate \< 50 beats/minute) or other Grade 2 or higher ECG abnormality. Participants with autoimmune conditions (e.g., asthma, psoriasis, etc.) Participants who are immunocompromised. Participants taking immunomodulatory, or anti-inflammatory, agents. Participants that are pregnant, breastfeeding, or plan to become pregnant within nine months of enrollment in the study. Female study participants of childbearing potential must remain abstinent or agree to use a highly effective form of contraception (e.g., an intrauterine device). Childbearing potential is defined as, study participants who have reached menarche and have not undergone a documented sterilization procedure (i.e., hysterectomy, bilateral oophorectomy, or salpingotomy), and have not reached menopause. Life history of bipolar disorder / schizophrenia / organic mental syndrome, or intellectual disability. Current alcohol / drug use disorder of greater than mild severity. Current suicidal ideation. History of a suicide attempt in the past year prior to study entry. Life history of \> 3 or more suicide attempts of any type. Life history of any moderately severe suicide attempt. Current or life history of homicidal ideation. Current or life history of felony assault and/or battery. Currently on parole for aggressive behavior. Allergy, or contraindication, to receiving endotoxin. Current treatment with opiates or any agents that affect pain threshold (exclusionary for the TAP). Unwilling/unable to sign informed consent document.
Contact & Investigator
Emil F. Coccaro, MD
PRINCIPAL INVESTIGATOR
The Ohio State University College of Medicine
Frequently Asked Questions
Who can join the NCT06665074 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 55 Years, studying Intermittent Explosive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06665074 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06665074 currently recruiting?
Yes, NCT06665074 is actively recruiting participants. Contact the research team at emil.coccaro@osumc.edu for enrollment information.
Where is the NCT06665074 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06665074 clinical trial?
NCT06665074 is sponsored by Ohio State University. The principal investigator is Emil F. Coccaro, MD at The Ohio State University College of Medicine. The trial plans to enroll 112 participants.