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Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

Biological Alterations of Laughing Gas Outcomes in Neurology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05540561
Acronym
BALON
Enrollment
356
Registered
2022-09-14
Start date
2023-01-30
Completion date
2026-07-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nitrous Oxide Abuse

Keywords

Nitrous Oxide, Neurology, Thrombosis, Biomarkers, Metabolis

Brief summary

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.

Interventions

OTHERblood collection

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood markers related to nitrous oxide consumptionthrough study completion an average of 1 yearBiomarkers of cobalamin metabolism, methionine cycle and oxidative stress

Secondary

MeasureTime frameDescription
Blood markers related to nitrous oxide clinical outcomes.Baseline, at 4 weeks, at 3 months and at 6 monthsBiomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage.
Estimated and self-reported nitrous oxide consumptionBaseline, at 4 weeks,and/or at 3 months and at 6 months
The severity of the clinical signs related to nitrous oxide consumption.Baseline, at 4 weeks,and/or at 3 months and at 6 monthsThe 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)

Countries

France

Contacts

CONTACTGuillaume Grzych, MD
guillaume.grzych@chu-lille.fr0320445962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026