Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00183105
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-05', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linkage to alcohol assistance'}, {'measure': 'Change in drinks per day'}], 'secondaryOutcomes': [{'measure': 'Change in the number of times a subject exceeded per occasion limits'}, {'measure': 'Abstinence (dichotomous)'}, {'measure': 'Change in drinks per day'}, {'measure': 'Drinking risky amounts (dichotomous)'}, {'measure': 'Binge drinking (dichotomous)'}, {'measure': 'Hospitalization'}, {'measure': 'Emergency Department visits'}, {'measure': 'Health related quality of life'}, {'measure': 'Readiness to change alcohol use'}]}, 'conditionsModule': {'keywords': ['Alcohol', 'Alcohol abuse', 'Alcohol dependence', 'Utilization', 'Alcohol consumption', 'Unhealthy alcohol use', 'Hospitalization', 'Screening', 'Brief Intervention', 'Motivational Interviewing', 'Randomized trial', 'Effectiveness', 'Unhealthy alcohol use (Risky alcohol consumption amounts, problem alcohol use, hazardous alcohol use, alcohol abuse and alcohol dependence)'], 'conditions': ['Alcohol Dependence', 'Alcohol Consumption']}, 'referencesModule': {'references': [{'pmid': '15908848', 'type': 'RESULT', 'citation': 'Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. doi: 10.1097/01.mlr.0000163644.97251.14.'}, {'pmid': '17283347', 'type': 'DERIVED', 'citation': 'Saitz R, Palfai TP, Cheng DM, Horton NJ, Freedner N, Dukes K, Kraemer KL, Roberts MS, Guerriero RT, Samet JH. Brief intervention for medical inpatients with unhealthy alcohol use: a randomized, controlled trial. Ann Intern Med. 2007 Feb 6;146(3):167-76. doi: 10.7326/0003-4819-146-3-200702060-00005.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.', 'detailedDescription': 'In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.\n\nWe conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Fluent in English or Spanish\n* Consume risky amounts of alcohol\n* Provide 2 contacts to assist with follow-up\n* Have no plans to move from the local area within a year of screening\n* Score \\>21 on Mini-Mental State Examination (no serious cognitive impairment)'}, 'identificationModule': {'nctId': 'NCT00183105', 'briefTitle': 'ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Hospital-based Brief Intervention for Alcohol Problems', 'orgStudyIdInfo': {'id': 'NIAAASaitz12617-ASAP'}, 'secondaryIdInfos': [{'id': 'P60AA013759', 'link': 'https://reporter.nih.gov/quickSearch/P60AA013759', 'type': 'NIH'}, {'id': 'NIH AA12617'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Brief Intervention (adaptation of motivational interviewing)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Richard Saitz, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}]}}}