Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04547751
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2019-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of new substances identified', 'timeFrame': 'Baseline', 'description': 'number of new substances identified'}], 'secondaryOutcomes': [{'measure': 'Active ingredients found', 'timeFrame': 'Baseline', 'description': 'Number of active ingredients found (including new substances'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drug abuse', 'chimique', 'High resolution mass spectrometry'], 'conditions': ['Drug Abuse']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* Age ≥ 14 years.\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT04547751', 'acronym': 'HOMACHI', 'briefTitle': 'Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI', 'orgStudyIdInfo': {'id': 'CHUBX 2018/27'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult', 'description': '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', 'interventionNames': ['Other: targeted high-resolution mass spectrometry']}, {'label': 'Minor', 'description': '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', 'interventionNames': ['Other: targeted high-resolution mass spectrometry']}], 'interventions': [{'name': 'targeted high-resolution mass spectrometry', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Adult', 'Minor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97600', 'city': 'Mayotte', 'state': 'France', 'country': 'France', 'facility': 'CH Mayotte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARS (Agence Régionale de Santé) Mayotte', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}