RecruitingPhase 2

Effect of Nitrous Oxide on Aggression.

United States50 participantsStarted 2022-09-06

Plain-language summary

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.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortico-Limbic Response to Anger Faces

Timeframe: 24 hours after Nitrous Oxide and Room Air

Brain Connectivity

Timeframe: 24 hours after Nitrous Oxide and Room Air

Trial details

NCT IDNCT06118567

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Jayla Copland, B.A.

614-327-1707 jayla.copland@osumc.edu

View on ClinicalTrials.gov More Intermittent Explosive Disorder trials