Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 1:02 PM
Study NCT ID:
NCT00523133
Status:
COMPLETED
Last Update Posted:
2007-08-31
First Post:
2007-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Individualized Treatment for Alcoholism
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': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-30', 'studyFirstSubmitDate': '2007-08-30', 'studyFirstSubmitQcDate': '2007-08-30', 'lastUpdatePostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Days Abstinent', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Percent Heavy Drinking Days', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['alcoholism', 'naltrexone', 'motivational enhancement therapy'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women between the ages of 21-65\n* current DSM-IV diagnosis of alcohol dependence\n* abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation\n* able to participate in an 18-month outpatient study\n* live within a one hour or less commute to Fairbanks\n* fluent in English\n* women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.\n* score as contemplators or greater on the Readiness For Change Scale\n\nExclusion Criteria:\n\n* severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)\n* opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year\n* pregnant or lactating females or those unwilling to use birth control\n* inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions\n* comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence\n* concomitant use of medications intended to decrease drinking (e.g. disulfiram)\n* meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression'}, 'identificationModule': {'nctId': 'NCT00523133', 'acronym': 'RITA', 'briefTitle': 'Research on Individualized Treatment for Alcoholism', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Posttreatment Effects of Naltrexone', 'orgStudyIdInfo': {'id': 'R01AA012696-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AA012696-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'naltrexone', 'type': 'DRUG', 'description': '50 mg naltrexone daily for 3 months'}, {'name': 'naltrexone', 'type': 'DRUG', 'description': '50 mg of naltrexone daily for 6 months'}, {'name': 'Broad Spectrum Treatment', 'type': 'BEHAVIORAL', 'description': '8-14, one hour sessions over 6 months'}, {'name': 'Motivational Enhancement Treatment', 'type': 'BEHAVIORAL', 'description': '4, 20 minute sessions over 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Hospital, Psychiatry Outpatient Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Dena Davidson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'VA Boston Healthcare System', 'class': 'FED'}, {'name': 'Brown University', 'class': 'OTHER'}, {'name': 'George Washington University', 'class': 'OTHER'}]}}}