Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse
ConditionNitrous Oxide Abuse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-65
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients using or having recently used nitrous oxide, and hospitalized during the study will be offered to participate in the study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
blood collection
Other interventionBiological analyses in the framework of care with conservation of blood samples
Treatment groups
356 Participants
are divided into 2 treatment groupsGroup A: Subjects consuming nitrous oxide with clinical outcomes1 intervention
Group B: Subjects consuming nitrous oxide without clinical outcomes1 intervention
Trial outcomes
Primary outcomes
1
Blood markers related to nitrous oxide consumption
Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress
Time frame
through study completion an average of 1 yearSecondary outcomes
1
Blood markers related to nitrous oxide clinical outcomes.
Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage.
Time frame
Baseline, at 4 weeks, at 3 months and at 6 months2
Estimated and self-reported nitrous oxide consumption
Time frame
Baseline, at 4 weeks,and/or at 3 months and at 6 months3
The severity of the clinical signs related to nitrous oxide consumption.
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)
Time frame
Baseline, at 4 weeks,and/or at 3 months and at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov