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NCT Number: NCT05540561

Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

There is a toxicity linked to the chronic use of nitrous oxide, leading to neurological disorders such as combined sclerosis of the spinal cord. One thus frequently observes patients presenting disorders of walking or paresthesias, of more or less resolving evolution being able to go until the need for using a wheelchair and more recently cases of thrombosis were reported Serum or urine N2O assays are rarely performed routinely, because they do not allow to ensure a real exposure due to the very short half-life of this gas in the body. Thus, other biological monitoring markers are mentioned in the literature, such as vitamin B12 or homocysteine. Unfortunately, there are still no recommendations for biological monitoring of nitrous oxide consumption. Moreover, underlying mechanisms leading to clinical outcomes remains misunderstood.

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Key information

Conditions

Nitrous Oxide Abuse Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulogne Sur Mer, Boulogne-sur-Mer, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A current or former recreational nitrous oxide user defined
  • With associated clinical signs (group 1)
  • Without associated clinical signs (group 2)
  • With or without clinico-biological sequelae associated with use
  • Consenting to the conduct of the study
  • Socially insured

Exclusion criteria

  • Pregnant or breastfeeding women
  • Never used nitrous oxide or stopped using it more than 6 months ago
  • Lack of social security coverage
  • Not willing to participate in the entire study

Treatment and study plan

Blood collection

Other

Biological analyses in the framework of care with conservation of blood samples

Primary outcomes

  1. Blood markers related to nitrous oxide consumption

    Time frame: through study completion an average of 1 year

    Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress

Secondary outcomes

  1. Blood markers related to nitrous oxide clinical outcomes.

    Time frame: Baseline, at 4 weeks, at 3 months and at 6 months

    Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage.

  2. Estimated and self-reported nitrous oxide consumption

    Time frame: Baseline, at 4 weeks,and/or at 3 months and at 6 months

  3. The severity of the clinical signs related to nitrous oxide consumption.

    Time frame: Baseline, at 4 weeks,and/or at 3 months and at 6 months

    The severity of the signs noted during the interrogation and consultation of the patients by filling out a pre-established form listing the neurological signs (gait disorders evaluated by the PND score, presence of paresthesia and associated clinical signs (thrombotic and psychiatric events)

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Grzych, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Biological Alterations of Laughing Gas Outcomes in Neurology

Acronym: BALON

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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