Clinical trial NCT05540561: Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse
Official title: Biological Alterations of Laughing Gas Outcomes in Neurology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nitrous Oxide Abuse
Keywords: Nitrous Oxide
Neurology
Thrombosis
Biomarkers
Metabolis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 356
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients using or having recently used nitrous oxide, and hospitalized during the study will be offered to participate in the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood markers related to nitrous oxide consumption
timeFrame: through study completion an average of 1 year
Secondary outcomes:
measure: Blood markers related to nitrous oxide clinical outcomes.
timeFrame: Baseline, at 4 weeks, at 3 months and at 6 months
measure: Estimated and self-reported nitrous oxide consumption
timeFrame: Baseline, at 4 weeks,and/or at 3 months and at 6 months
measure: The severity of the clinical signs related to nitrous oxide consumption.
timeFrame: Baseline, at 4 weeks,and/or at 3 months and at 6 months
Other outcomes:
Locations:
city: Bethune
country: France
facility: BETHUNE
city: Boulogne Sur Mer
country: France
facility: Boulogne Sur Mer
city: Calais
country: France
facility: CALAIS
city: Lens
country: France
facility: Lens
city: Lille
country: France
facility: Chu Lille
city: Nantes
country: France
facility: Nantes
city: Roubaix
country: France
facility: Roubaix
city: Rouen
country: France
facility: Rouen
Study officials:
References: