Study on Detecting Nitrous Oxide in Healthy Volunteers Using Nitrous Oxide and Oxygen to Help Victims of Nitrous Oxide Intoxication

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What is this study about?

This clinical trial is focused on studying the effects of nitrous oxide, commonly known as “laughing gas,” in healthy volunteers. The study aims to understand how long nitrous oxide can be detected in the body after exposure. This research is important for helping victims of crimes involving nitrous oxide. The study will also involve the use of paracetamol, a mild pain reliever, and oxygen, a gas essential for breathing, to support the research process.

The main purpose of the study is to measure the concentration of nitrous oxide in the blood after exposure and determine how long it remains detectable. Participants will inhale nitrous oxide, and researchers will monitor how long it takes for the gas to no longer be present in the blood, breath, and other bodily fluids. The study will also check if routine screening methods can detect nitrous oxide and related markers in the body.

Participants in the study will be healthy adults who will provide informed consent. They will be monitored closely to ensure their safety throughout the study. The trial will help improve understanding of nitrous oxide exposure and its detection, which can be crucial in forensic investigations. The study is expected to continue until 2027, with recruitment starting in late 2024.

1 joining the study

Upon joining the study, you will be required to provide informed, written consent. This means you agree to participate after understanding the details of the study.

You must be a healthy volunteer aged between 18 and 65 years and able to understand Danish.

You will need to confirm your willingness and ability to use safe contraception for 24 hours after gas exposure.

2 initial assessment

An initial assessment will be conducted to ensure you meet all the criteria for participation.

This assessment will include a review of your health status and any other necessary evaluations.

3 exposure to study medication

You will be exposed to nitrous oxide through inhalation. This is the main part of the study.

The objective is to investigate how long nitrous oxide can be detected in your body after exposure.

4 monitoring and testing

After exposure, your blood, exhaled breath, oral fluid, and urine will be tested to measure nitrous oxide levels.

The study aims to determine the time it takes for nitrous oxide levels to no longer be significantly increased compared to a placebo group.

5 follow-up assessments

You will undergo follow-up assessments to monitor the levels of nitrous oxide and other possible biomarkers in your body.

These assessments will help verify if routine screening methods can detect nitrous oxide and its effects.

6 completion of participation

Your participation will conclude once the study objectives have been met and all necessary data has been collected.

You will be informed about the end of your participation and any further steps, if applicable.

Who Can Join the Study?

Healthy volunteers aged 18-65 years
Provide informed, written consent, which means you agree to participate after understanding the study
Able to understand the Danish language
Participants must be willing and able to use safe contraception for 24 hours after gas exposure. Contraception refers to methods used to prevent pregnancy.

Who Cannot Join the Study?

Patients who have had nitrous oxide intoxication recently cannot participate. Nitrous oxide intoxication means having too much nitrous oxide, a gas sometimes used for pain relief, in the body.
Patients who are under the age of 18 cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with any serious medical conditions that might interfere with the study cannot participate.
Patients who are unable to give informed consent cannot participate. Informed consent means understanding the details of the study and agreeing to take part.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Aldceo Uqkppfmquq Hfxzjclq	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Nitrous Oxide is a colorless gas commonly used for its anesthetic and pain-relieving effects. In this clinical trial, the focus is on understanding how nitrous oxide behaves in the body after someone has been exposed to it. The study aims to measure the levels of nitrous oxide in the blood and determine how long it can be detected after exposure. This information could be useful in situations where nitrous oxide exposure is involved, such as in certain crimes. Participants in the trial will be exposed to nitrous oxide, and researchers will monitor how the gas is processed and eliminated by the body over time.

Nitrous oxide intoxication – Nitrous oxide intoxication occurs when a person inhales excessive amounts of nitrous oxide, commonly known as laughing gas. This can lead to a range of symptoms due to its effects on the nervous system. Initially, individuals may experience euphoria, dizziness, and a sense of detachment from reality. As exposure continues, more severe symptoms can develop, such as confusion, impaired motor function, and incoordination. Prolonged exposure may result in vitamin B12 deficiency, leading to neurological issues. The progression of symptoms depends on the duration and concentration of exposure.

Trial ID:

2024-517234-18-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Detecting Nitrous Oxide in Healthy Volunteers Using Nitrous Oxide and Oxygen to Help Victims of Nitrous Oxide Intoxication

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?