Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood collection.
- Who it may be relevant to
- Registry conditions: Nitrous Oxide Abuse. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biological Alterations of Laughing Gas Outcomes in Neurology
Overview
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
- Other blood collection
Biological analyses in the framework of care with conservation of blood samples
Primary outcome measures
- Blood markers related to nitrous oxide consumption [Time frame: through study completion an average of 1 year]
Secondary outcome measures (3)
- Blood markers related to nitrous oxide clinical outcomes. [Time frame: Baseline, at 4 weeks, at 3 months and at 6 months]
- Estimated and self-reported nitrous oxide consumption [Time frame: Baseline, at 4 weeks,and/or at 3 months and at 6 months]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 8 centers
- BETHUNE — Béthune
- Boulogne Sur Mer — Boulogne-sur-Mer
- CALAIS — Calais
- Lens — Lens
- Chu Lille — Lille
- Nantes — Nantes
- Roubaix — Roubaix
- Rouen — Rouen
Identifiers
NCT: NCT05540561 · 2021_0461 · 2022-A00327-36