Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT06084832
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smartphone Application for University Students With Binge Drinking Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D063425', 'term': 'Binge Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 628}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the number of standard drinks per week', 'timeFrame': '30 months'}], 'secondaryOutcomes': [{'measure': 'Change of the PEth concentration', 'timeFrame': '3 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '6 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '9 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '12 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '15 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '18 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '21 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '24 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '27 months', 'description': 'phosphatidylethanol (PEth)'}, {'measure': 'Change of the PEth concentration', 'timeFrame': '30 months', 'description': 'phosphatidylethanol (PEth)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol', 'Binge Drinking', 'Phosphatidylethanol', 'Smartphone', 'Health'], 'conditions': ['Alcohol Drinking', 'Binge Drinking']}, 'referencesModule': {'references': [{'pmid': '40165584', 'type': 'DERIVED', 'citation': 'Andre C, Sauton P, Dreinaza M, Diouf M, Bodeau S, Martinetti M, Trouillet R, de Groote C, Nandrino JL, Alexandre A, Benzerouk F, Gierski F, Perney P, Grellet L, Andre J, Naassila M. Effect of the MyDefi Smartphone Application on Binge Drinking Among University Students: Protocol of a Double-Blind Multicenter Prospective National Randomized Controlled Trial Using Phosphatidylethanol as a Biomarker-The SMARTBINGE Trial. Int J Methods Psychiatr Res. 2025 Jun;34(2):e70014. doi: 10.1002/mpr.70014.'}]}, 'descriptionModule': {'briefSummary': 'Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students between 18 and 25 years old\n* AUQ score greater than or equal to 24, and AUDIT score greater than or equal to 3 for its first 3 items. Drinking details with the DDQ when necessary.\n* BD behavior: at least one occasion with 6 or more drinks in the last 3 months.\n* Consent to be included in the study\n* Affiliated to social security\n\nExclusion Criteria:\n\n* Not having a smartphone with an Apple or Android system.\n* Previous use of the MyDéfi smartphone application\n* Declaration of a psychiatric / neurologic condition\n* Pregnant, parturient or breastfeeding woman\n* Subject under guardianship, curators or restricted under public law'}, 'identificationModule': {'nctId': 'NCT06084832', 'acronym': 'SmartBinge', 'briefTitle': 'Smartphone Application for University Students With Binge Drinking Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Smartphone Application for University Students With Binge Drinking Behavior: National Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PI2023_843_0069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Binge Drinking', 'interventionNames': ['Biological: blood microsampling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Binge Drinking-control', 'interventionNames': ['Biological: blood microsampling']}], 'interventions': [{'name': 'blood microsampling', 'type': 'BIOLOGICAL', 'description': 'blood microsampling for the measure of Phosphatidylethanol', 'armGroupLabels': ['Binge Drinking', 'Binge Drinking-control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandra BODEAU, Dr', 'role': 'CONTACT', 'email': 'bodeau.sandra@chu-amiens.fr', 'phone': '+33322087029'}, {'name': 'Mickael Naasila, Pr', 'role': 'CONTACT', 'email': 'mickael.naassila@u-picardie.fr', 'phone': '03.22.82.76.72'}, {'name': 'Pierre SAUTON', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Farid BENZEROUK, DR', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Louis NANDRINO, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raphaël TROUILLET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Mickael Naasila, Pr', 'role': 'CONTACT', 'email': 'mickael.naassila@u-picardie.fr', 'phone': '03.22.82.76.72'}, {'name': 'Sandra Bodeau, Dr', 'role': 'CONTACT', 'email': 'bodeau.sandra@chu-amiens.fr', 'phone': '03.22.08.70.34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'EPSM Marne, Reims', 'class': 'UNKNOWN'}, {'name': 'SCA-LAB UMR-CNRS 9193, Lille', 'class': 'UNKNOWN'}, {'name': 'Paul Valery University, Montpellier', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}