NCT07690358

Brief Summary

The study examines the concentrations of nitrous oxide that are achieved in blood, exhaled air, and urine after three different exposures to nitrous oxide: inhalation of three or four cartridges of nitrous oxide released in a car cabin in a switched-off car, consumption of 100 g of whipped cream in which nitrous oxide is used as a propellant, and exposure through work as a midwife in a delivery room. The concentrations in blood and exhaled air are measured for up to 1 hour after exposure, and in urine for up to 2 hours after exposure. The concentrations in blood and urine are measued with gas chromatography and mass spectrometry, while the concentration in exhaled air is measured by a sensor using an NDIR sensor (Olythe, France).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 29, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Nitrous oxideForensic chemistrydriving under the influencelaughing gas

Outcome Measures

Primary Outcomes (1)

  • Detection time of Nitrous Oxide in blood

    The time after exposure in which Nitrous Oxide can be detected in blood

    From end of exposure to 1 hour after end of exposure

Study Arms (4)

Passive exposure in car, 3 cartridges

EXPERIMENTAL

A person sits for 15 minutes after releasing 4 x 8.4 g of nitrous oxide into the cabin

Other: Nitrous Oxide 99 %

Passive exposure in car, 4 cartridges

EXPERIMENTAL

A person sits for 15 minutes after releasing 4 x 8.4 g of nitrous oxide into the cabin

Other: Nitrous Oxide 99 %

Whipped cream, 100 g

EXPERIMENTAL

A person ingests 100 g of whipped cream with nitrous oxide as propellant

Other: Nitrous Oxide 99 %

Environmental exposure

ACTIVE COMPARATOR

concentrations of nitrous oxide are measured after exposure through work as a midwife in a delivery room

Other: Nitrous Oxide + Oxygen Gas

Interventions

Passive exposure to Nitrous Oxide

Passive exposure in car, 3 cartridgesPassive exposure in car, 4 cartridgesWhipped cream, 100 g

Midwifes are exposed through work in a delivery room

Environmental exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Able to understand Danish
  • Willing to use effective contraception for 24 hours after the end of exposure (oral contraceptives, contraceptive implant, transdermal patch, vaginal ring, or injectable contraceptives)
  • Written informed consent

You may not qualify if:

  • Current or past abuse of drugs, nitrous oxide (N₂O), or alcohol
  • A psychiatric disorder requiring medical treatment, including severe depression
  • A diagnosis of epilepsy
  • Symptoms of peripheral neuropathy
  • Significant cardiac or pulmonary disease
  • Previous allergic or adverse reaction to N₂O
  • Diving within the past 2 days
  • Inability to refrain from diving for 2 days after the study
  • Occupational exposure to N₂O
  • Use of N₂O within the past 3 months
  • Treatment with methotrexate, benzodiazepines, opioids, or other centrally depressant drugs
  • Recent intraocular gas injection
  • Known impaired liver or kidney function
  • Pregnant or breastfeeding women (fertile women, defined as amenorrhea for less than 12 months, must have a negative hCG pregnancy test prior to receiving the study intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Forensic Medicine

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Driving Under the Influence

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous Behavior

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Central Study Contacts

Charlotte U Andersen, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations