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Biological Diagnosis and Monitoring of Chronic Nitrous Oxide Abuse

NCT ID: NCT05540561

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2025-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Nitrous Oxide Abuse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

blood collection

Intervention Type OTHER

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.

blood collection

Intervention Type OTHER

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

Interventions

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blood collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BETHUNE

Béthune, , France

Site Status RECRUITING

Boulogne Sur Mer

Boulogne-sur-Mer, , France

Site Status RECRUITING

CALAIS

Calais, , France

Site Status RECRUITING

Lens

Lens, , France

Site Status RECRUITING

Chu Lille

Lille, , France

Site Status RECRUITING

Nantes

Nantes, , France

Site Status RECRUITING

Roubaix

Roubaix, , France

Site Status RECRUITING

Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume Grzych, MD

Role: CONTACT

[email protected]
0320445962 ext. +33

Facility Contacts

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GUILLAUME GROLEZ, Dr

Role: primary

[email protected]
03 21 64 44 44

MATHIEU BATAILLE

Role: primary

[email protected]
03 21 99 30 30

OLIVIER DEREEPER

Role: primary

[email protected]
0321463360

JULIEN LANNOY, DR

Role: primary

[email protected]
0321691511

Guillaume Grzych, MD

Role: primary

[email protected]
0320445962

YANN PEREON, Dr

Role: primary

[email protected]
33 240 083 704

ADELINE ENDERLE, Dr

Role: primary

[email protected]
03 20 99 14 77

LUCIE GUYANT, Dr

Role: primary

[email protected]
0232888037

Other Identifiers

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2022-A00327-36

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0461

Identifier Type: -

Identifier Source: org_study_id

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