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Nitrous Oxide for Aggression

Phase 2

Recruiting

Led By Emil Coccaro, M.D.

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).

Between 21 and 55 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after nitrous oxide and room air

Awards & highlights

Study Summary

This trial tests if Nitrous Oxide can help impulsively aggressive people by normalizing brain circuit function. Participants inhale it and have an MRI scan 24 hrs later.

Who is the study for?

This trial is for adults aged 21-55 with Intermittent Explosive Disorder (IED) and high aggression scores, but no major psychiatric disorders like psychosis or bipolar disorder, nor current severe substance abuse. Healthy participants without any psychiatric conditions and low aggression can also join.Check my eligibility

What is being tested?

Researchers are testing if inhaling Nitrous Oxide changes brain function in people with impulsive aggression compared to healthy controls. Participants breathe in either Nitrous Oxide or room air for an hour and have a brain scan the next day.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of Nitrous Oxide may include dizziness, nausea, fatigue, headache or euphoria shortly after inhalation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am physically healthy with no significant medical conditions.

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I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after nitrous oxide and room air

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after nitrous oxide and room air

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after nitrous oxide and room air for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain Connectivity

Cortico-Limbic Response to Anger Faces

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nitrous Oxide InhalationActive Control1 Intervention

60 minute session inhaling Nitrous Oxide gas.

Group II: Room AirPlacebo Group1 Intervention

60 minute session inhaling Room Air.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,659 Total Patients Enrolled

1 Trials studying Intermittent Explosive Disorder

90 Patients Enrolled for Intermittent Explosive Disorder

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,570 Total Patients Enrolled

3 Trials studying Intermittent Explosive Disorder

209 Patients Enrolled for Intermittent Explosive Disorder

Emil Coccaro, M.D.Principal InvestigatorThe Ohio State University Wexner Medical Center

1 Previous Clinical Trials

144 Total Patients Enrolled

1 Trials studying Intermittent Explosive Disorder

144 Patients Enrolled for Intermittent Explosive Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this trial's cohort?

"Affirmative. Clinicaltrials.gov has the latest information that this clinical trial, which was first posted on September 6th 2022, is currently recruiting participants. Approximately 50 patients are needed from a single medical site."

Answered by AI

Who is eligible to take part in this research study?

"To be eligible for this clinical trial, individuals must have intermittent explosive disorder and be between 21 to 55 years old. The study is looking for 50 volunteers in total."

Answered by AI

Does this medical experiment have any open positions?

"Affirmative. As per the information detailed on clinicaltrials.gov, this medical trial is recruiting patients now. It was originally posted to the platform on September 6th 2022 and edited most recently November 1st 2023. Currently, 50 individuals are sought from one site for participation in this study."

Answered by AI

Are participants aged 40 and over being accepted for this trial?

"This clinical trial will include patients who are between 21 and 55 years old."

Answered by AI

Is Nitrous Oxide Inhalation a safe route of treatment for those in need?

"Our team at Power believes that the safety of nitrous oxide inhalation is a 2 due to Phase 2 trial data indicating some evidence for its security, yet no proof of efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Nitrous Oxide on Aggression.

Emil Coccaro 2022. "Effect of Nitrous Oxide on Aggression.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118567.