NCT05540561

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

October 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 12, 2022

Last Update Submit

October 22, 2024

Conditions

Nitrous Oxide Abuse

Keywords

Nitrous OxideNeurologyThrombosisBiomarkersMetabolis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Blood markers related to nitrous oxide clinical outcomes.

    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.

    Baseline, at 4 weeks,and/or at 3 months and at 6 months

Study Arms (2)

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

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

Interventions

blood collectionOTHER

Biological analyses in the framework of care with conservation of blood samples

Subjects consuming nitrous oxide with clinical outcomesSubjects consuming nitrous oxide without clinical outcomes

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

BETHUNE

BĂ©thune, France

RECRUITING

Boulogne Sur Mer

Boulogne-sur-Mer, France

RECRUITING

CALAIS

Calais, France

RECRUITING

Lens

Lens, France

RECRUITING

Chu Lille

Lille, France

RECRUITING

Nantes

Nantes, France

RECRUITING

Roubaix

Roubaix, France

RECRUITING

Rouen

Rouen, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Guillaume Grzych, MD

CONTACT

0320445962guillaume.grzych@chu-lille.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 14, 2022

Study Start

January 30, 2023

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

October 26, 2024

Record last verified: 2024-09

Locations

FR(8)