Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse (BALON)

University Hospital, Lille

Status: Enrolling

Conditions: Nitrous Oxide Abuse

Treatments: Other: blood collection

Study type: Observational

Funder types: Other

Identifiers

NCT05540561

2022-A00327-36 (Other Identifier)

2021_0461

Details and patient eligibility

About

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.

Enrollment: 356 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

356 participants in 2 patient groups

Subjects consuming nitrous oxide with clinical outcomes

Description:

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.

Treatment:

Other: blood collection

Subjects consuming nitrous oxide without clinical outcomes

Description:

Subjects who consume nitrous oxide who do not present clinical signs related to this consumption and recruited during a routine medical consultation.

Treatment:

Other: blood collection