Recruiting

Phase 2

Nitrous OxideEffect of Nitrous Oxide on Aggression.

Sponsor:

Ohio State University

Code:

NCT06118567

Conditions

Intermittent Explosive Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Nitrous oxide

Room Air

Study Details

Brief 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.

Conditions

Intermittent Explosive Disorder

Study ID

NCT06118567

Start date

Sep 6, 2022

Status verified date

Mar, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Nitrous Oxide Inhalation

60 minute session inhaling Nitrous Oxide gas.

sham comparator: Room Air

60 minute session inhaling Room Air.

Interventions

Nitrous oxide

Nitrous oxide gas.

Room Air

Primary outcome measure

Cortico-Limbic Response to Anger Faces [ Time Frame: 24 hours after Nitrous Oxide and Room Air ]
Brain Connectivity [ Time Frame: 24 hours after Nitrous Oxide and Room Air ]

Central Contacts and Locations

Central contacts

Jayla Copland, B.A.

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

Julian Roberts, R.N.

julian.roberts@osumc.edu

Locations

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-03-27.