ClinicalTrials.gg
RecruitingNCT06118567Updated Mar 27, 2025

Effect of Nitrous Oxide on Aggression.

A Phase 2 interventional study of Nitrous oxide and Room Air in Intermittent Explosive Disorder, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Ohio State University · Phase 2, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2022, registered Nov 2023).
  • Started Sep 2022; still recruiting 4 years 2 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Disruptive, Impulse Control, and Conduct Disorders · United States.

Planned enrollment
13th of 28
50 · median 48
Started
2022
the only one that year
Phase 2
14 of 31
4 open now
Registered
26th of 31
by date
Lead sponsor
5 of 31
Ohio State University

Among the 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States, this one is the 13th largest by planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2022, is one of 14 in phase 2, and was the 26th registered.

Disruptive, Impulse Control, and Conduct Disorders

56 studies on the registry are indexed under Disruptive, Impulse Control, and Conduct Disorders; 17 are open to participants now.

Browse Disruptive, Impulse Control, and Conduct Disorders studies →

Open to participants now

8 of the 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 15 Disruptive, Impulse Control, and Conduct Disorders studies recruiting now, 4 (27%) set no upper age limit and 10 (67%) stop at 75 or younger; none take children under 18; 5 take healthy volunteers.

This study: 21 Years to 55 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

This study is designed to see if inhalation of 50% nitrous oxide (N2O) also known as laughing gas, can normalize cortico-limbic circuit functioning in impulsively aggressive human subjects. If the study results are positive, it would allow further studies of this potential treatment modality for those with recurrent, problematic, impulsive aggressive behavior (Intermittent Explosive Disorder: IED). IED is a disorder in which there are frequent and sudden outbursts of anger (yelling, throwing and breaking things, hitting people) that lead to problems with other people socially or at work. It affects about 4% of the US population lifetime, and does not have any approved treatments. The study will test if N2O can normalize brain activity 24 hours after infusion, in participants with a diagnosis of IED compared with healthy, non-aggressive, controls. This is a double-blinded-randomized study with comparison between groups (controls and IED patients) and comparison for each participant between N2O and placebo (air) inhalation. Participants will receive one type of inhalation 24 hours before undergoing an fMRI. Participants will be randomized to the order in which they receive N2O or air. Participants and study personnel involved in collection of outcome measures will be blinded to the type of inhalation. The study includes up to 7 visits. Visits 1/2 include interviews and questionnaires. At visits 3 and 5, participants receive the N2O or air inhalation. At visits 4 and 6, participants undergo fMRI while completing computer tasks. Visit 7 is to assure data collection is complete.

03

Conditions studied

  • Intermittent Explosive Disorder

Keywords

  • IED
04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All participants:

  • Between 21 and 55 years of age.
  • Physically healthy (no medical condition as confirmed by medical history/physical exam).
  • Able to give .

Aggressive (IED) Study Participants (n = 25 Completed; 75 Enrolled).

  • Current 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

Exclusion Criteria:

  • PCL Screening Version Score > 13; i.e., subject is likely to be psychopathic.32
  • Current Major Depressive Episode.
  • Life history of bipolar disorder/schizophrenia/organic mental syndrome.
  • Intellectual disability [i.e., IQ \< 70].
  • History of N2O abuse/dependence.
  • 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 document.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Nitrous Oxide Inhalation

    60 minute session inhaling Nitrous Oxide gas.

    Drug: Nitrous oxide

  • Sham comparator
    Room Air

    60 minute session inhaling Room Air.

    Drug: Room Air

Interventions

06

What researchers measure

Primary outcomes

  1. Cortico-Limbic Response to Anger Faces

    Orbito-Frontal and Amygdala responses to Anger Faces in fMRI

    Time frame: 24 hours after Nitrous Oxide and Room Air

  2. Brain Connectivity

    Resting State

    Time frame: 24 hours after Nitrous Oxide and Room Air

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2022 (actual). Primary completion is estimated for Aug 2027, 59 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2023
First posted
Nov 7, 2023
StartActual
Sep 6, 2022
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06118567
Responsible party
Emil Coccaro (Professor, Ohio State University) — Principal investigator
First posted
Nov 7, 2023
Start date
Sep 6, 2022
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Mar 27, 2025

Study contacts

Jayla Copland, B.A.
Contact
jayla.copland@osumc.edu
614-327-1707
Julian Roberts, R.N.
Contact
julian.roberts@osumc.edu
Emil Coccaro, M.D.
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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