Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

Recruiting

• Conditions: Nitrous Oxide Abuse
• Interventions: Other: blood collection

• Registration Number: NCT05540561
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2023-01-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects consuming nitrous oxide with clinical outcomes	blood collection	Subjects who consume nitrous oxide and who have been hospitalized in this context and who present clinical signs determined during a neurological evaluation according to the PND (Peripheral Neuropathy Disability) score or who have had a thrombotic accident related to the consumption of nitrous oxide.
Subjects consuming nitrous oxide without clinical outcomes	blood collection	Subjects who consume nitrous oxide who do not present clinical signs related to this consumption and recruited during a routine medical consultation.

Primary Outcome Measures

Name	Time	Method
Blood markers related to nitrous oxide consumption	through study completion an average of 1 year	Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress

Secondary Outcome Measures

Name	Time	Method
The severity of the clinical signs related to nitrous oxide consumption.	Baseline, at 4 weeks,and/or at 3 months and at 6 months	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)
Blood markers related to nitrous oxide clinical outcomes.	Baseline, at 4 weeks, at 3 months and at 6 months	Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage.
Estimated and self-reported nitrous oxide consumption	Baseline, at 4 weeks,and/or at 3 months and at 6 months

Trial Locations

Locations (8)

BETHUNE; 🇫🇷 Bethune, France

Boulogne Sur Mer; 🇫🇷 Boulogne Sur Mer, France

CALAIS; 🇫🇷 Calais, France

Lens; 🇫🇷 Lens, France

Chu Lille; 🇫🇷 Lille, France

Nantes; 🇫🇷 Nantes, France

Roubaix; 🇫🇷 Roubaix, France

Rouen; 🇫🇷 Rouen, France