NCT05540561 Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse
| NCT ID | NCT05540561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Nitrous Oxide Abuse |
| Study Type | OBSERVATIONAL |
| Enrollment | 356 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 356 participants in total. It began in 2023-01-30 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05540561 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Nitrous Oxide Abuse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05540561 currently recruiting?
Yes, NCT05540561 is actively recruiting participants. Contact the research team at guillaume.grzych@chu-lille.fr for enrollment information.
Where is the NCT05540561 trial being conducted?
This trial is being conducted at Béthune, France, Boulogne-sur-Mer, France, Calais, France, Lens, France and 4 additional locations.
Who is sponsoring the NCT05540561 clinical trial?
NCT05540561 is sponsored by University Hospital, Lille. The trial plans to enroll 356 participants.