Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-18 @ 8:56 PM
Study NCT ID:
NCT02087358
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2014-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol Consumption and Stress at Patients Alcohol-dependants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'CRHR1 gene polymorphisisme'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress level', 'timeFrame': '3 weeks follow-up', 'description': 'correlation between stress and alcohol related craving using a prospective ecological design'}], 'secondaryOutcomes': [{'measure': 'Genetic association with stress level', 'timeFrame': '3 weeks follow-up', 'description': 'Correlation between stress and alcohol related craving using a prospective ecological design stratified for CRHR1 variant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcohol dependence', 'Stress- correlation', 'genetic', 'CRHR1'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.', 'detailedDescription': 'This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes alcohol dependent inpatients participating in a 3 weeks detoxification program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Males or Females aged 18-65 years\n* Alcohol use disorder defined by DSM 5 criteria\n* Fluent in French\n* Hospitalized for alcohol withdrawal for at least 7 days\n* Viable (working) telephone number\n\nExclusion criteria:\n\n* Participants without social care insurance\n* Any DSM Axis I disorder not defined in the inclusion criteria\n* Mandatory psychiatric treatment'}, 'identificationModule': {'nctId': 'NCT02087358', 'acronym': 'CASPA', 'briefTitle': 'Alcohol Consumption and Stress at Patients Alcohol-dependants', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Alcohol Consumption and Stress at Patients Alcohol-dependants', 'orgStudyIdInfo': {'id': 'P110908'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stress and craving', 'description': 'This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92701', 'city': 'Colombes', 'country': 'France', 'facility': 'Hopital Louis Mourier, Service de psychiatrie', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Yann Le Strat, Pr MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatrist Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}