Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-24 @ 4:41 PM
Study NCT ID:
NCT00194103
Status:
COMPLETED
Last Update Posted:
2010-06-28
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Extended Telephone Monitoring
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-25', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TimeLineFollowBack', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry\n* qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);\n* willingness to participate in research and be randomized;\n* 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);\n* able to provide the names of several informants who will know his/her whereabouts during the follow-up period\n\nExclusion Criteria:\n\n* acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);\n* IV heroin use during the past year;\n* anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.'}, 'identificationModule': {'nctId': 'NCT00194103', 'acronym': 'ETM', 'briefTitle': 'Effectiveness of Extended Telephone Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'orgStudyIdInfo': {'id': '708753'}, 'secondaryIdInfos': [{'id': 'R01AA014850', 'link': 'https://reporter.nih.gov/quickSearch/R01AA014850', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'TAU'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone Monitoring', 'interventionNames': ['Behavioral: Telephone Monitoring and Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone Monitoring and Counseling', 'interventionNames': ['Behavioral: Telephone Monitoring and Counseling']}], 'interventions': [{'name': 'Telephone Monitoring and Feedback', 'type': 'BEHAVIORAL', 'description': 'In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.', 'armGroupLabels': ['Telephone Monitoring']}, {'name': 'Telephone Monitoring and Counseling', 'type': 'BEHAVIORAL', 'description': 'In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.', 'armGroupLabels': ['Telephone Monitoring and Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'James McKay, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. James R McKay, PhD', 'oldOrganization': 'University of Pennsylvania'}}}}