Nitrous OxideNCNCT04301024
Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users in Montpellier
An observational study of Nitrous Oxide and Drug Abuse, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Nitrous Oxide, Drug Abuse
- What is being tested?
- assessing the nitrous oxide misuse
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: teenagers and young adults consulting in an addictology center dedicated to young drug abusers in Montpellier
Who may be able to join
- teenagers and young adults consulting in an addictology center dedicated to young abusers in Montpellier and who agree with being included in the study
Who cannot join
- to refuse to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users: an Observational Study Led in Montpellier
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.
Read more
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.
- Conditions
- Nitrous Oxide, Drug Abuse
- Being tested
- assessing the nitrous oxide misuse
- Keywords
- screening, spotting
- Medical subject headings
- Substance-Related Disorders, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessing the nitrous oxide misuseOther
assessing the nitrous oxide misuse among teenagers consulting in an addioctology center dedicated to young drug users in montpellier
| Study group | Role | What they receive |
|---|---|---|
| nitrous oxide misusers | nitrous oxide misusers among the teenagers consulting in an addictology center dedicated to young drug users in Montpellier Receives: Other: assessing the nitrous oxide misuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
nitrous oxide misuse
Description of Nitrous oxide misuse based to answers of a self report questionnaire
Measured: 1 day
Secondary outcomes (2)
use of other drugs (cannabis, tobacco, alcohol, cocaine, heroine)
the use of other drugs (cannabis, tobacco, alcohol, cocaine, heroine. Use of other drug rated by screening test ( CAST ; AUDIT ; Fagerström)
Measured: 1 day
Assess of the side effect based to answers
Assess of the side effect based to answers of a self report questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start30 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitrous OxideStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion Ambrosino, medical resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301024
- Sponsor's protocol ID
- RECHMPL20_0116
- Acronym
- NC
- Status last verified
- Nov 2020
- First submitted
- 4 Mar 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users: an Observational Study Led in Montpellier
- ClinicalTrials.gov ID
- NCT04301024
- Acronym / sponsor ID
- NC / RECHMPL20_0116
- Conditions
- Nitrous Oxide, Drug Abuse
- Keywords
- screening, spotting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nitrous oxide misusers | – | Other: assessing the nitrous oxide misusenitrous oxide misusers among the teenagers consulting in an addictology center dedicated to young drug users in Montpellier |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- teenagers and young adults consulting in an addictology center dedicated to young drug abusers in Montpellier
Key inclusion criteria (1 listed)
- teenagers and young adults consulting in an addictology center dedicated to young abusers in Montpellier and who agree with being included in the study
Key exclusion criteria (1 listed)
- to refuse to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessing the nitrous oxide misuseassessing the nitrous oxide misuse among teenagers consulting in an addioctology center dedicated to young drug users in montpellier | Other | nitrous oxide misusers |
Primary outcome
nitrous oxide misuse
Time frame: 1 day
Description of Nitrous oxide misuse based to answers of a self report questionnaire
2 secondary outcomes
use of other drugs (cannabis, tobacco, alcohol, cocaine, heroine)
Time frame: 1 day
Assess of the side effect based to answers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Ambrosino, medical resident principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nitrous Oxide and Drug Abuse, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nitrous oxide misuse (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.