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

May 18, 2026 updated by: University Hospital, Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Boulogne-sur-Mer, France
        • Recruiting
        • Boulogne Sur Mer
        • Contact:
        • Principal Investigator:
          • MATHIEU BATAILLE, Dr
      • Béthune, France
        • Recruiting
        • BETHUNE
        • Contact:
        • Principal Investigator:
          • GUILLAUME GROLEZ, Dr
      • Calais, France
        • Recruiting
        • CALAIS
        • Contact:
        • Principal Investigator:
          • OLIVIER DEREEPER, Dr
      • Lens, France
        • Recruiting
        • Lens
        • Contact:
        • Principal Investigator:
          • JULIEN LANNOY, Dr
      • Lille, France
        • Recruiting
        • CHU Lille
        • Contact:
        • Principal Investigator:
          • Guillaume Grzych, MD
      • Nantes, France
        • Recruiting
        • Nantes
        • Contact:
        • Principal Investigator:
          • YANN PEREON, Dr
      • Roubaix, France
        • Recruiting
        • Roubaix
        • Contact:
        • Principal Investigator:
          • ADELINE ENDERLE, Dr
      • Rouen, France
        • Recruiting
        • Rouen
        • Contact:
        • Principal Investigator:
          • LUCIE GUYANT, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood markers related to nitrous oxide consumption
Time Frame: through study completion an average of 1 year
Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress
through study completion an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood markers related to nitrous oxide clinical outcomes.
Time Frame: 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.
Baseline, at 4 weeks, at 3 months and at 6 months
Estimated and self-reported nitrous oxide consumption
Time Frame: Baseline, at 4 weeks,and/or at 3 months and at 6 months
Baseline, at 4 weeks,and/or at 3 months and at 6 months
The severity of the clinical signs related to nitrous oxide consumption.
Time Frame: 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)
Baseline, at 4 weeks,and/or at 3 months and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021_0461
  • 2022-A00327-36 (Other Identifier: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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