NCT04301024

Brief Summary

Nitrous oxide gas is used in several application areas : medical as an anesthetic drug ; in food industry as a foaming and a mixing agent ; industrial to speed combustion. It is also misused for its hilarant, euphoric and hallucinogenic effect. For this purpose the gas is transfered in a balloon to be inhaled. As its effects are briefs, its consumption is often perseived as safe. However, some risks exist and are majorated by the way of use and for some groups of people. Since 2016, the French observatory of drug and substances addiction (OFDT) describes an increasing misuse of nitrous oxide amoung teenagers and young adults. In november 2019, a french press release alerts on the recent increasing of neurologic side effects related to the misuse of nitrous oxide. That's why, it seems to be interesting to improve the screening of nitrous oxide abuse, in particular amoung adolescents and young adults. In our study, the investigators would like to determine the characteristics (social, medical, any drug abuse) of teenagers and young adults who misuse nitrous oxide. Through a questionnaire, the investigators plan to select teenagers and young adults who consult in an addictology center dedicated to young drug consumers in Montpellier. This questionnaire is anonymous. The data will be collected only after obtaining the patient's agreement. The final goal is to create a tool to help general practitioners in screening young people at risk of nitrous oxyde misuse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

March 4, 2020

Last Update Submit

November 23, 2020

Conditions

Nitrous OxideDrug Abuse

Keywords

screeningspotting

Outcome Measures

Primary Outcomes (1)

  • nitrous oxide misuse

    Description of Nitrous oxide misuse based to answers of a self report questionnaire

    1 day

Secondary Outcomes (2)

  • use of other drugs (cannabis, tobacco, alcohol, cocaine, heroine)

    1 day

  • Assess of the side effect based to answers

    1 day

Study Arms (1)

nitrous oxide misusers

nitrous oxide misusers among the teenagers consulting in an addictology center dedicated to young drug users in Montpellier

Other: assessing the nitrous oxide misuse

Interventions

assessing the nitrous oxide misuseOTHER

assessing the nitrous oxide misuse among teenagers consulting in an addioctology center dedicated to young drug users in montpellier

nitrous oxide misusers

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

teenagers and young adults consulting in an addictology center dedicated to young drug abusers in Montpellier

You may qualify if:

  • \- teenagers and young adults consulting in an addictology center dedicated to young abusers in Montpellier and who agree with being included in the study

You may not qualify if:

  • \- to refuse to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Substance-Related DisordersMetrorrhagia

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marion Ambrosino, medical resident

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

March 30, 2020

Primary Completion

June 30, 2020

Study Completion

September 30, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

FR(1)