Testing nitrous oxide for reducing aggression in impulsive individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: jayla.copland@osumc.edu
• Phone: 614-327-1707

Similar studies

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• Using Pimavanserin to Reduce Aggression in Intermittent Explosive Disorder

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.