Study on the Effects of Nitrous Oxide and Oxygen on Driving Ability in Healthy Volunteers After Recreational Use

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What is this study about?

This clinical trial is focused on understanding the effects of the recreational use of nitrous oxide, commonly known as “laughing gas,” on driving ability. The study involves healthy volunteers who use nitrous oxide while driving a vehicle. The main goal is to learn how quickly nitrous oxide is eliminated from the body by measuring its concentration in the blood after a short recreational intake.

Participants in the study will inhale a medicinal gas called Kalinox, which is a combination of nitrous oxide and oxygen. Another medicinal gas, Medicinsk Oxygen “Strandmøllen”, which contains only oxygen, will also be used. The study will observe the effects of these gases on driving ability before, during, and after their use, using a driving simulator to mimic real driving conditions.

The study aims to provide insights into how nitrous oxide affects driving performance and how long it stays in the body. This information could be important for understanding the risks associated with using nitrous oxide while driving. The trial will help determine the blood concentration levels of nitrous oxide and assess driving ability under its influence.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be at least 18 years old, hold a Danish driving license for at least one year, have driven at least 200 km in the past year, provide informed consent, and be able to read and understand Danish.

2 initial assessment

An initial assessment is conducted to ensure all criteria are met. This includes verifying driving experience and understanding of the study requirements.

3 recreational intake of nitrous oxide

Participants will inhale a medicinal gas called nitrous oxide mixed with oxygen. This is done through a process called inhalation, where the gas is breathed in. The gas is compressed and administered in a controlled environment.

4 blood sample collection

Blood samples are collected to measure the concentration of nitrous oxide in the body. This helps in understanding how the gas is eliminated from the body over time.

5 driving simulation

Participants will engage in a driving simulation to assess driving ability before, during, and after the intake of nitrous oxide. This is done using a medium-fidelity driving simulator to ensure safety and accuracy in measuring driving performance.

6 completion of study

Upon completion of all assessments and simulations, participation in the study concludes. Results from the blood samples and driving simulation are analyzed to understand the effects of nitrous oxide on driving ability and its elimination from the body.

Who Can Join the Study?

Must be 18 years or older.
Must have had a Danish driving license for at least one year.
Must have at least 200 km of driving experience in the last year.
Must provide informed consent, which means you agree to participate after understanding the study.
Must be able to read and understand Danish.

Who Cannot Join the Study?

People who use substances for fun while driving a vehicle cannot participate.
Only healthy volunteers are allowed to join the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Nitrous Oxide is a gas that is sometimes used for recreational purposes because it can make people feel relaxed and happy. In this clinical trial, the researchers are studying how nitrous oxide affects the body, especially how it is processed and eliminated from the blood after being inhaled. The goal is to understand how nitrous oxide might impact a person’s ability to drive safely after using it. This information is important for determining how long someone should wait before driving after using nitrous oxide recreationally.

Recreational Nitrous Oxide Use – Recreational nitrous oxide use involves inhaling nitrous oxide gas for its euphoric effects. The gas is rapidly absorbed through the lungs and enters the bloodstream, leading to a quick onset of effects. Users may experience a sense of euphoria, dizziness, and altered perception. The effects are typically short-lived, lasting only a few minutes. As the gas is eliminated from the body, normal sensory and motor functions gradually return. Repeated use can lead to temporary impairment of coordination and cognitive functions.

Trial ID:

2023-509993-49-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Nitrous Oxide and Oxygen on Driving Ability in Healthy Volunteers After Recreational Use

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