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

Biological Alterations of Laughing Gas Outcomes in Neurology

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nitrous Oxide Abuse
• Intervention / Treatment: Other: blood collection

• Study Type: Observational
• Enrollment (Anticipated): 356

Contacts and Locations

• Study Contact: Name: Guillaume Grzych, MD; Phone Number: +33 0320445962; Email: guillaume.grzych@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients using or having recently used nitrous oxide, and hospitalized during the study will be offered to participate in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects consuming nitrous oxide with clinical outcomes; 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.	Other: blood collection; Biological analyses in the framework of care with conservation of blood samples
Subjects consuming nitrous oxide without clinical outcomes; Subjects who consume nitrous oxide who do not present clinical signs related to this consumption and recruited during a routine medical consultation.	Other: blood collection; Biological analyses in the framework of care with conservation of blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Estimated and self-reported nitrous oxide consumption		Baseline, at 4 weeks,and/or at 3 months and at 6 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (ACTUAL): September 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Thrombosis; Biomarkers; Nitrous Oxide; Neurology; Metabolis
• Other Study ID Numbers: 2021_0461; 2022-A00327-36 (OTHER: 2022-A00327-36)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No