Status:
RECRUITING
Effect of Nitrous Oxide on Aggression.
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Intermittent Explosive Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
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 wi...
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06118567
Start Date
September 6 2022
End Date
August 31 2027
Last Update
March 27 2025
Active Locations (1)
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1
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210