Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT02860195
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The determination of ethanol in the plasma', 'timeFrame': '6 months', 'description': 'blood samples'}], 'secondaryOutcomes': [{'measure': 'measures in the exhaled air', 'timeFrame': '6 months', 'description': 'Assessed with the device Alcotest®'}, {'measure': 'sweat alcohol concentration', 'timeFrame': '6 months', 'description': 'assessed with a Transdermal monitor'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['The Sweat Alcohol Concentration']}, 'descriptionModule': {'briefSummary': "A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration.\n\nOne of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods.\n\nThe purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18-40 years, age-matched (+ 3 years)\n* Caucasian\n* BMI: 19 to 28 kg/m2\n* No smoking or light smoker (\\<5 cig/d)\n* Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience\n\nExclusion Criteria:\n\n* Subjects with addiction to toxic or alcohol (MINI Questionnaire)\n* Positive individuals in search of drugs and toxic\n* Anxiety or depressive subjects (IASTA Questionnaires and BDI)'}, 'identificationModule': {'nctId': 'NCT02860195', 'acronym': 'ALCOOCAPT', 'briefTitle': 'Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration', 'orgStudyIdInfo': {'id': '2016-12'}, 'secondaryIdInfos': [{'id': '2016-A00729-42', 'type': 'REGISTRY', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'interventionNames': ['Other: oral dose of alcohol', 'Device: alcotest', 'Biological: blood samples', 'Device: Transdermal monitor']}], 'interventions': [{'name': 'oral dose of alcohol', 'type': 'OTHER', 'armGroupLabels': ['healthy volunteers']}, {'name': 'alcotest', 'type': 'DEVICE', 'armGroupLabels': ['healthy volunteers']}, {'name': 'blood samples', 'type': 'BIOLOGICAL', 'armGroupLabels': ['healthy volunteers']}, {'name': 'Transdermal monitor', 'type': 'DEVICE', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine GEINDRE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}, {'name': 'OLIVIER BLIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}