Nitrous Oxide for Aggression
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Ohio State University
Must not be taking: Antipsychotics
Disqualifiers: Psychopathy, Depression, Schizophrenia, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests if inhaling nitrous oxide can help normalize brain function in people with impulsive aggression. Participants with and without aggressive tendencies will inhale the gas and undergo brain scans to see if it improves their brain activity. The goal is to find a potential treatment for those with Intermittent Explosive Disorder. Nitrous oxide has been shown to reduce involuntary movements in cerebral palsy patients, indicating its potential to affect brain function.
Will I have to stop taking my current medications?
The trial requires participants to be free of antipsychotic medication for two weeks before joining. However, if you are taking SSRIs, SNRIs, or mood stabilizers, you can continue using them as long as you still experience impulsive aggressive behaviors.
What data supports the effectiveness of the drug nitrous oxide for treating aggression?
Nitrous oxide is known for its anesthetic and pain-relieving properties, making it useful in various medical settings. Its ability to be safely administered by trained professionals and even self-administered by patients suggests it could have potential in managing conditions like aggression, although specific studies on aggression are not mentioned.
12345Is nitrous oxide generally safe for human use?
Nitrous oxide is generally considered safe when used in medical settings, like dentistry, for its anesthetic and anti-anxiety effects. However, heavy or prolonged use can lead to vitamin B12 deficiency, causing nerve damage and blood problems. Recreational use can also lead to accidents and, in rare cases, serious health issues.
36789How is nitrous oxide different from other drugs for treating aggression?
Nitrous oxide is unique because it is traditionally used as an anesthetic and for its calming effects in dentistry, but it is now being explored for its potential to treat psychiatric conditions like aggression at lower, non-anesthetic doses. This approach is novel compared to standard treatments, which typically involve medications like antipsychotics or mood stabilizers.
13101112Eligibility Criteria
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.Inclusion Criteria
Aggressive (IED) Study Participants (n = 25 Completed; 75 Enrolled):
Negative for a history of psychosis, bipolar disorder, developmental disorder, intellectual disability or a current substance use disorder.
I am physically healthy with no significant medical conditions.
+8 more
Exclusion Criteria
Intellectual disability [i.e., IQ < 70].
History of N2O abuse/dependence.
I have a serious health condition.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
2 visits (in-person)
Treatment
Participants undergo a 60 minute inhalation session with 50% Nitrous Oxide or room air, followed by an fMRI scan 24 hours later
1 week
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
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.
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.
Nitrous Oxide is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Nitrous oxide for:
- Anesthesia
- Pain relief
- Hypoxic respiratory failure in neonates
🇺🇸 Approved in United States as Nitrous oxide for:
- Anesthesia
- Pain relief
- Hypoxic respiratory failure in neonates
🇨🇦 Approved in Canada as Nitrous oxide for:
- Anesthesia
- Pain relief
- Hypoxic respiratory failure in neonates
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State University Wexner Medical CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Recreational nitrous oxide abuse related subacute combined degeneration of the spinal cord in adolescents - A case series and literature review. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Nitrous oxide (N2O) is a commonly used inhaled anesthetic in outpatient dental procedures. However, the increasing recreational use of N2O may result in vitamin B12 deficiency-related neurologic and psychiatric symptoms. The aim of this study was to demonstrate the clinical features of chronic N2O abuse in pediatric patients.
Limited analgesic efficacy of nitrous oxide for painful procedures in children. [2022]Nitrous oxide (N(2)O) is an attractive agent for procedural analgesia and sedation of children in the emergency department (ED). Despite increasing use, efficacy data for painful procedures are limited. This study aimed to determine pain scores during ED procedural sedation with N(2)O in the ED setting.
Subacute combined degeneration induced by nitrous oxide inhalation: Two case reports. [2022]Nitrous oxide (N2O), commonly known as "laughing gas," is being increasingly abused by young people as a recreational drug; this can subsequently result in myelopathy and peripheral neuropathy, however, in China, few cases of neurologic deterioration by N2O abuse have been reported.
Reversible Neuropsychiatric Disturbances Caused by Nitrous Oxide Toxicity: Clinical, Imaging and Electrophysiological Profiles of 21 Patients with 6-12 Months Follow-up. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Nitrous oxide (N2O) abuse has become an increasingly severe problem in China. The aim of the study was to summarize the features of N2O-induced neurology and enhance the awareness of this disease among physicians.
Update on nitrous oxide and its use in anesthesia practice. [2019]Nitrous oxide (N2O) is an anesthetic and analgesic gas with a long history of medical applications. It acts on multiple supraspinal and spinal targets and has utility in a wide range of clinical situations. The relative safety, low incidence, and acuity of adverse effects of N2O, along with the ability to be administered by trained medical providers with varying clinical backgrounds, as well as self-administered by patients, assure its persistent and expanding role in clinical practice.
Recreational nitrous oxide use: Prevalence and risks. [2022]Nitrous oxide (N2O; laughing gas) is clinically used as a safe anesthetic (dentistry, ambulance, childbirth) and appreciated for its anti-anxiety effect. Since five years, recreational use of N2O is rapidly increasing especially in the dance and festival scene. In the UK, N2O is the second most popular recreational drug after cannabis. In most countries, nitrous oxide is a legal drug that is widely available and cheap. Last month prevalence of use among clubbers and ravers ranges between 40 and almost 80 percent. Following one inhalation, mostly from a balloon, a euphoric, pleasant, joyful, empathogenic and sometimes hallucinogenic effect is rapidly induced (within 10 s) and disappears within some minutes. Recreational N2O use is generally moderate with most users taking less than 10 balloons of N2O per episode and about 80% of the users having less than 10 episodes per year. Side effects of N2O include transient dizziness, dissociation, disorientation, loss of balance, impaired memory and cognition, and weakness in the legs. When intoxicated accidents like tripping and falling may occur. Some fatal accidents have been reported due to due to asphyxia (hypoxia). Heavy or sustained use of N2O inactivates vitamin B12, resulting in a functional vitamin B12 deficiency and initially causing numbness in fingers, which may further progress to peripheral neuropathy and megaloblastic anemia. N2O use does not seem to result in dependence. Considering the generally modest use of N2O and its relative safety, it is not necessary to take legal measures. However, (potential) users should be informed about the risk of vitamin B12-deficiency related neurological and hematological effects associated with heavy use.
Case report of an acute myocardial infarction after high-dose recreational nitrous oxide use: a consequence of hyperhomocysteinaemia? [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Nitrous oxide (N2O, laughing gas) is increasingly used as a recreational drug and is presumed relatively safe and innocent. It is often being used in combination with other substances, such as cannabis.
[Not Available]. [2019]«Laughing gas» (nitrous oxide N2O) has analgesic and sedative properties and is commonly used in dentistry because of its many advantages (ease of use, dose titration, rapid onset, lack of prolonged effects, both analgetic and anxiolytic effects). However, nitrous oxide may cause vitamin B12 deficiency, has abuse liability, and occupational exposure has been associated with infertility, spontaneous abortion, blood dyscrasias, and neurologic deficits. Scavenger systems are recommended to minimize exposure and personnel should be informed about the potential risks.
Nitrous oxide-induced reproductive risks: Should recreational nitrous oxide users worry? [2022]Label="BACKGROUND">Nitrous oxide (N2O) is a frequently used anaesthetic. Since the year 2000, recreational use of N2O, also known as 'laughing gas', became popular as a recreational drug due to its mild psychedelic effect. In the 1980s, several reports warned against N2O-induced reproductive risks among healthcare personnel, questioning the occupational safety of N2O in health care.
Mini-Review: A Brief History of Nitrous Oxide (N2O) Use in Neuropsychiatry. [2020]Joseph Priestley's discovery of nitrous oxide (N2O) was recorded in 1772. In the late 1790's, Humphry Davy experimented with the psychotropic properties of N2O, describing his observations in a book, published in 1800. A dentist, Horace Wells discovered anaesthesia with N2O in 1844. Over a century after Davy, its potential usefulness in psychiatry was first recognised. The seminal researches in neuropsychiatry, between 1920 and 1950, mainly used anaesthetic concentrations of the gas. The psychotropic actions of N2O, at non-anaesthetic doses, were first used by dentists, mainly for its anxiolytic action. In modern dentistry, N2O is always mixed with at least 30% oxygen and titrated to doses rarely exceeding 40% of N2O. At these lower concentrations, untoward effects are almost always avoided, including over-sedation and/or anaesthesia. In the early 1980's, the low-dose dental titration technique was first used to investigate and treat psychiatric conditions, including substance abuse. Until then, most physicians regarded the gas only as an anaesthetic agent. An exception was obstetricians who used a fixed 50% concentration of N2O diluted with oxygen for analgesia during parturition. In 1994, to clearly distinguish between anaesthetic and non-anaesthetic concentrations (as used in dentistry), the term Psychotropic Analgesic Nitrous oxide (PAN) was introduced.
Accidental death by nitrous oxide inhalation. [2019]Nitrous oxide is a popular inhalation anesthetic-analgesic agent. Its euphoric action and its availability have led to its abuse. We report a case of fatal accidental asphyxia due to nitrous oxide abuse. The deceased was a hospital worker who had access to the hospital supply of nitrous oxide. His death was due to hypoxemia and asphyxiation, secondary to nitrous oxide inhalation.
Nitrous oxide "whippit" abuse presenting with cobalamin responsive psychosis. [2021]Nitrous oxide is a commonly abused inhalant drug. It is known to precipitate vitamin B12 deficiency when used chronically and acutely, especially in people having marginal vitamin B12 reserve.