RECRUITING

Effect of Nitrous Oxide on Aggression.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Nitrous Oxide and Cortico-Limbic Function in Aggression

Quick Facts

Study Start:2022-09-06
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06118567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 21 and 55 years of age.
  2. * Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).
  3. * Able to give informed consent.
  4. * Current DSM-5 Criteria for IED
  5. * LHA Aggression scores \> 12
  6. * Negative for a history of psychosis, bipolar disorder, developmental disorder, intellectual disability or a current substance use disorder.
  7. * Do not meet current/lifetime DSM-5 Criteria for any psychiatric disorder
  8. * LHA aggression scores \< 12
  1. * PCL Screening Version Score \> 13; i.e., subject is likely to be psychopathic.32
  2. * Current DSM-5 Major Depressive Episode.
  3. * Life history of bipolar disorder/schizophrenia/organic mental syndrome.
  4. * Intellectual disability \[i.e., IQ \< 70\].
  5. * History of N2O abuse/dependence.
  6. * Clinically significant medical condition.
  7. * 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).
  8. * 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.)
  9. * Unwilling/unable to sign informed consent document.

Contacts and Locations

Study Contact

Jayla Copland, B.A.
CONTACT
614-327-1707
jayla.copland@osumc.edu
Julian Roberts, R.N.
CONTACT
julian.roberts@osumc.edu

Principal Investigator

Emil Coccaro, M.D.
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center

Study Locations (Sites)

Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Emil Coccaro, M.D., PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-06
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-09-06
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • IED

Additional Relevant MeSH Terms

  • Intermittent Explosive Disorder