Testing nitrous oxide for reducing aggression in impulsive individuals

Nitrous Oxide and Cortico-Limbic Function in Aggression

This study is testing if breathing in nitrous oxide can help people with Intermittent Explosive Disorder and healthy individuals by seeing if it changes how their brains work when it comes to controlling aggression.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 21 Years to 55 Years
• Sex: All
• Sponsor: Ohio State University (other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06118567 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate whether inhalation of nitrous oxide can normalize brain circuit function in individuals with Intermittent Explosive Disorder (IED) and healthy controls. Participants will undergo a 60-minute inhalation session of either 50% nitrous oxide or room air, followed by an fMRI scan 24 hours later to assess changes in cortico-limbic circuit functioning. The study is designed as a double-blind, randomized trial, comparing the effects of nitrous oxide against a placebo in both groups. The findings could pave the way for new treatment options for those suffering from impulsive aggression.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 to 55 with a diagnosis of Intermittent Explosive Disorder and significant aggression scores.

Not a fit: Patients with a history of psychosis, bipolar disorder, or current substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a novel treatment for individuals with Intermittent Explosive Disorder, potentially improving their quality of life.

How similar studies have performed: While the use of nitrous oxide in this context is novel, similar studies exploring its effects on brain function have shown promising results.

Eligibility criteria

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 this trial is running

Columbus, Ohio

• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Emil Coccaro, M.D. — Ohio State University
• Study coordinator: Jayla Copland, B.A.

Conditions: Intermittent Explosive Disorder, IED