Effect of Nitrous Oxide on Aggression.

NCT06118567 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020H0368
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

IED

Outcome Measures

Primary Outcomes (2)

• Cortico-Limbic Response to Anger Faces

  Orbito-Frontal and Amygdala responses to Anger Faces in fMRI

  24 hours after Nitrous Oxide and Room Air

• Brain Connectivity

  Resting State

  24 hours after Nitrous Oxide and Room Air

Study Arms (2)

Nitrous Oxide Inhalation

ACTIVE COMPARATOR

60 minute session inhaling Nitrous Oxide gas.

Drug: Nitrous oxide

Room Air

SHAM COMPARATOR

60 minute session inhaling Room Air.

Drug: Room Air

Interventions

Nitrous oxide DRUG

Nitrous oxide gas.

Nitrous Oxide Inhalation

Room Air DRUG

Room Air

Room Air

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Emil Coccaro, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayla Copland, B.A.

CONTACT

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

Julian Roberts, R.N.

CONTACT

julian.roberts@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Room air (vs. Nitrous Oxide Inhalation)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: September 6, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)