Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT03276520
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ethyl glucuronide positive rate', 'timeFrame': 'after six months of ongoing urine screening', 'description': 'Percentage of patients screening positive to EtG at study end in each group'}, {'measure': 'descending of Etg positive rates in the Etg group', 'timeFrame': 'six months of ongoing urine screening', 'description': 'varying rate of EtG positive patinets in the intervention group during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ethyl glucuronide, biomarker, diagnostic randomized trial'], 'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.\n\nMethods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.\n\nExclusion Criteria:\n\n* conditions rendering patients unable to complete study procedures'}, 'identificationModule': {'nctId': 'NCT03276520', 'briefTitle': 'Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.', 'orgStudyIdInfo': {'id': 'HCB/2015/0984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ethyl glucuronide', 'description': 'subjects being screened with ethyl glucuronide', 'interventionNames': ['Diagnostic Test: ethyl glucuronide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ethanol', 'description': 'subjects being screened with ethanol', 'interventionNames': ['Diagnostic Test: ethanol']}], 'interventions': [{'name': 'ethyl glucuronide', 'type': 'DIAGNOSTIC_TEST', 'description': 'alcohol urine screening with ethyl glucuronide', 'armGroupLabels': ['ethyl glucuronide']}, {'name': 'ethanol', 'type': 'DIAGNOSTIC_TEST', 'description': 'alcohol urine screening with ethanol', 'armGroupLabels': ['ethanol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Addictive Behaviors Unit', 'investigatorFullName': 'Antoni Gual', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}