NCT06118567 · Ohio State University
Effect of Nitrous Oxide on Aggression.
What this study is about
The goal of this experimental medicine clinical trial is to test the hypothesis that nitrous oxide inhalation will result in a change in neurocircuit function in healthy controls and in individuals with impulsive aggressive tendencies. The main question aims to answer are: Does Nitrous Oxide normalize brain circuit function in impulsively aggressive individuals 24 hours after inhalation.
View original scientific description
The goal of this experimental medicine clinical trial is to test the hypothesis that nitrous oxide inhalation will result in a change in neurocircuit function in healthy controls and in individuals with impulsive aggressive tendencies. The main question aims to answer are: Does Nitrous Oxide normalize brain circuit function in impulsively aggressive individuals 24 hours after inhalation. Participants will undergo a 60 minute inhalation session with 50% Nitrous Oxide (or room air at another session) and then undergo an fMRI scan 24 hours later. Researchers will compare healthy controls and impulsively aggressive individuals to see if Nitrous Oxide can normalize the function of cortico-limbic circuits in the latter group.
Interventions
DRUG
Nitrous oxide
Nitrous oxide gas.
DRUG
Room Air
Room Air
Primary outcome measures
Cortico-Limbic Response to Anger Faces
Time frame: 24 hours after Nitrous Oxide and Room Air
Orbito-Frontal and Amygdala responses to Anger Faces in fMRI
Brain Connectivity
Time frame: 24 hours after Nitrous Oxide and Room Air
Resting State
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All participants:
- Between 21 and 55 years of age.
- Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).
- Able to give informed consent. Aggressive (IED) Study Participants (n = 25 Completed; 75 Enrolled).
- Current DSM-5 Criteria for IED
- LHA Aggression scores \> 12
- Negative for a history of psychosis, bipolar disorder, developmental disorder, intellectual disability or a current substance use disorder. Healthy, Non-Aggressive, Controls (n = 25 Completed, 75 Enrolled).
- Do not meet current/lifetime DSM-5 Criteria for any psychiatric disorder
- LHA aggression scores \< 12
Exclusion criteria
- PCL Screening Version Score \> 13; i.e., subject is likely to be psychopathic.32
- Current DSM-5 Major Depressive Episode.
- Life history of bipolar disorder/schizophrenia/organic mental syndrome.
- Intellectual disability \[i.e., IQ \< 70\].
- History of N2O abuse/dependence.
- Clinically significant medical condition.
- Current alcohol/drug use disorder of moderate or severe severity (i.e., subject is not in full remission from moderate to severe alcohol/drug use).
- Two weeks free of antipsychotic medication. (Note: Because a large number of individuals with aggressive tendencies in the community are already taking SSRIs, SNRIs, or mood stabilizers, these individuals will not be excluded if they continue to report impulsive aggressive behaviors at time of study.)
- Unwilling/unable to sign informed consent document.
Where
- Columbus, Ohio
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2025 · Source of record for eligibility and locations