Monitoring the effects of chronic nitrous oxide use
Biological Alterations of Laughing Gas Outcomes in Neurology
University Hospital, Lille · NCT05540561
This study looks at people who use nitrous oxide to see if certain blood markers can help us understand the health risks and effects of this substance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 356 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 8 sites (Béthune and 7 other locations) |
| Trial ID | NCT05540561 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the biological diagnosis and monitoring of individuals who abuse nitrous oxide, a substance linked to serious neurological disorders. It aims to identify potential biomarkers, such as vitamin B12 and homocysteine levels, that could indicate the extent of nitrous oxide exposure and its associated health risks. Participants will include current or former users of nitrous oxide, categorized based on their clinical signs and symptoms. Blood samples will be collected to analyze these biomarkers and better understand the underlying mechanisms of nitrous oxide-related health issues.
Who should consider this trial
Good fit: Ideal candidates for this study are current or former recreational nitrous oxide users, with or without clinical signs of toxicity.
Not a fit: Patients who have never used nitrous oxide or have stopped using it for more than six months will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients suffering from the effects of nitrous oxide abuse.
How similar studies have performed: While there is limited research specifically on nitrous oxide abuse, studies on other substance abuses have shown success in identifying biomarkers for monitoring health impacts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Béthune and 7 other locations
- BETHUNE — Béthune, France (RECRUITING)
- Boulogne Sur Mer — Boulogne-sur-Mer, France (RECRUITING)
- CALAIS — Calais, France (RECRUITING)
- Lens — Lens, France (RECRUITING)
- Chu Lille — Lille, France (RECRUITING)
- Nantes — Nantes, France (RECRUITING)
- Roubaix — Roubaix, France (RECRUITING)
- Rouen — Rouen, France (RECRUITING)
Study contacts
- Study coordinator: Guillaume Grzych, MD
- Email: guillaume.grzych@chu-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nitrous Oxide Abuse, Nitrous Oxide, Neurology, Thrombosis, Biomarkers, Metabolis