Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

Nitrous Oxide Abuse Clinical Trial

— BALON  

Official title:

Biological Alterations of Laughing Gas Outcomes in Neurology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540561
• Other study ID #: 2021_0461
• Secondary ID: 2022-A00327-36
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: Guillaume Grzych, MD
• Phone: 0320445962
• Email: guillaume.grzych[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nitrous Oxide Abuse

Intervention

Other:
• blood collection
Biological analyses in the framework of care with conservation of blood samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood markers related to nitrous oxide consumption	Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress	through study completion an average of 1 year
Secondary	Blood markers related to nitrous oxide clinical outcomes.	Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress and biological markers of neurological damage.	Baseline, at 4 weeks, at 3 months and at 6 months
Secondary	Estimated and self-reported nitrous oxide consumption		Baseline, at 4 weeks,and/or at 3 months and at 6 months
Secondary	The severity of the clinical signs related to nitrous oxide consumption.	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)	Baseline, at 4 weeks,and/or at 3 months and at 6 months