Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT00249366
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Alcohol Withdrawal in Hospital Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008140', 'term': 'Lorazepam'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-08', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Withdrawal Assessment Scores', 'timeFrame': 'participants were followed for the duration of hospital stay, the median length of stay was 3 days', 'description': 'Difference in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores between study arms'}, {'measure': 'Total Dose of Lorazepam', 'timeFrame': 'participants were followed for the duration of hospital stay, the median length of stay was 3 days', 'description': 'Differences in total amount of lorazepam administered between protocol groups'}, {'measure': 'Protocol Errors', 'timeFrame': 'participants were followed for the duration of hospital stay, the median length of stay was 3 days', 'description': 'Percentage of protocol errors between study arms, such as administration of an inappropriate lorazepam dose (inconsistent with CIWA-Ar score); excluded complications due to comorbid medical conditions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol withdrawal', 'Symptom-triggered therapy', 'Fixed-schedule therapy', 'CIWA-Ar', 'Lorazepam (drug)'], 'conditions': ['Alcohol Withdrawal Syndrome']}, 'referencesModule': {'references': [{'pmid': '16785215', 'type': 'RESULT', 'citation': 'Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.', 'detailedDescription': 'Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)\n* Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment\n* Patients on the General Internal Medicine service\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Chronically maintained on prescription sedative-hypnotics'}, 'identificationModule': {'nctId': 'NCT00249366', 'briefTitle': 'Treatment of Alcohol Withdrawal in Hospital Patients', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Acute Drug Withdrawal in a General Medical Setting', 'orgStudyIdInfo': {'id': 'NIAAAWEA-K2300222-A'}, 'secondaryIdInfos': [{'id': 'K23AA000222', 'link': 'https://reporter.nih.gov/quickSearch/K23AA000222', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-schedule treatment', 'description': 'Fixed-schedule administration of lorazepam for alcohol withdrawal', 'interventionNames': ['Drug: Lorazepam (drug)', 'Drug: Lorazepam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symptom-triggered treatment', 'description': 'Symptom-triggered administration of lorazepam per protocol using the Clinical Institute Withdrawal Assessment for Alcohol, revised version (CIWA-Ar)', 'interventionNames': ['Drug: Lorazepam (drug)', 'Drug: Lorazepam']}], 'interventions': [{'name': 'Lorazepam (drug)', 'type': 'DRUG', 'otherNames': ['Ativan'], 'description': 'Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients', 'armGroupLabels': ['Fixed-schedule treatment', 'Symptom-triggered treatment']}, {'name': 'Lorazepam', 'type': 'DRUG', 'otherNames': ['Ativan'], 'description': 'Lorazepam administered orally or IV for treatment of alcohol withdrawal in hospitalized patients', 'armGroupLabels': ['Fixed-schedule treatment', 'Symptom-triggered treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Michael F. Weaver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}