Drug AbuseHOMACHINCT04547751
Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI
An observational study of Drug Abuse, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Drug Abuse
- What is being tested?
- targeted high-resolution mass spectrometry
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2020to 5 Feb 2021
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance
Who may be able to join
- Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required;
- Age ≥ 14 years.
Who cannot join
- Patient without parental authority for minor patients aged 14yrs; Patient not included in the exception article 59 of the law of January 6th, 1978 modified for patient aged 15yrs and older
Trial locations and contacts
1 site in 1 country.
About this study
The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.
Read the detailed description
The CEIP-A of Bordeaux (in charge of French overseas departments) has been commissioned by the MILD\&CA in 2015 to reinforce the links between local caregivers and the addictoviligance's inquieries. In particular, the CEIP-A has been alerted about a drug called " chimique " in Mayotte, leading to many hospitalizations. Most of the patients are less than 18 year old or are young adulthoods. For all patients who have agreed to participate in this study, the remainder of the blood sample will be reused for a drop of blood on blotting paper; the remainder of the remainder will be stored in the heparinized tube. Medical data collected in the emergency department will also be collected. All the data will be analyzed by the pharmacology and toxicology laboratory of the Bordeaux University Hospital
- Conditions
- Drug Abuse
- Being tested
- targeted high-resolution mass spectrometry
- Keywords
- drug abuse, chimique, High resolution mass spectrometry
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted high-resolution mass spectrometryOther
difference between the number of new substances identified using targeted analysis by liquid chromatography coupled with high-resolution mass spectrometry versus using targeted analysis. "narcotics-new substance" by liquid chromatography coupled with tandem mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Adult | Patients aged 18yrs and older hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required Receives: Other: targeted high-resolution mass spectrometry | |
| Minor | Patients aged 14-17yrs and older hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required Receives: Other: targeted high-resolution mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of new substances identified
number of new substances identified
Measured: Baseline
Secondary outcomes (1)
Active ingredients found
Number of active ingredients found (including new substances
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start6 Jun 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- ARS (Agence Régionale de Santé) Mayotte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547751
- Sponsor's protocol ID
- CHUBX 2018/27
- Acronym
- HOMACHI
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI
- ClinicalTrials.gov ID
- NCT04547751
- Acronym / sponsor ID
- HOMACHI / CHUBX 2018/27
- Conditions
- Drug Abuse
- Keywords
- drug abuse, chimique, High resolution mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- ARS (Agence Régionale de Santé) Mayotte
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 14 Sep 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.
The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.
Detailed description
The CEIP-A of Bordeaux (in charge of French overseas departments) has been commissioned by the MILD\&CA in 2015 to reinforce the links between local caregivers and the addictoviligance's inquieries. In particular, the CEIP-A has been alerted about a drug called " chimique " in Mayotte, leading to many hospitalizations. Most of the patients are less than 18 year old or are young adulthoods. For all patients who have agreed to participate in this study, the remainder of the blood sample will be reused for a drop of blood on blotting paper; the remainder of the remainder will be stored in the heparinized tube. Medical data collected in the emergency department will also be collected. All the data will be analyzed by the pharmacology and toxicology laboratory of the Bordeaux University Hospital
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult | – | Other: targeted high-resolution mass spectrometryPatients aged 18yrs and older hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required |
| Minor | – | Other: targeted high-resolution mass spectrometryPatients aged 14-17yrs and older hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance
Key inclusion criteria (2 listed)
- Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required;
- Age ≥ 14 years.
Key exclusion criteria (1 listed)
- Patient without parental authority for minor patients aged 14yrs; Patient not included in the exception article 59 of the law of January 6th, 1978 modified for patient aged 15yrs and older
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 |
|---|---|---|
| targeted high-resolution mass spectrometrydifference between the number of new substances identified using targeted analysis by liquid chromatography coupled with high-resolution mass spectrometry versus using targeted analysis. "narcotics-new substance" by liquid chromatography coupled with tandem mass spectrometry | Other | Adult, Minor |
Primary outcome
number of new substances identified
Time frame: Baseline
number of new substances identified
1 secondary outcome
Active ingredients found
Time frame: Baseline
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 12 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug Abuse, run by University Hospital, Bordeaux 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 2 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 12 Apr 2022. 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?
number of new substances identified (time frame: Baseline). 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 12 Apr 2022.