Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT00000451
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
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': 'D020280', 'term': 'Sertraline'}, {'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '1999-11-02', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days abstinent'}]}, 'conditionsModule': {'keywords': ['Alcoholism', 'Alcohol Dependence'], 'conditions': ['Alcoholism', 'Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alaska Native having biological Alaska Native ancestry.\n* Meets criteria for alcohol dependence.\n* Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.\n* Stable residence to ensure that subjects can be located during the study.\n\nExclusion Criteria:\n\n* Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.\n* Current use of disulfiram.\n* Psychotic or otherwise severely psychiatrically disabled.\n* Use of other psychotropic medications including antidepressants and anxiolytics.\n* Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.\n* Hepatocellular disease or elevated bilirubin levels.\n* Females who are pregnant, nursing, or not using a reliable method of birth control.\n* Probation or parole requirements that might interfere with participation in the study.\n* Involvement in alcohol treatment other than provided by the study or AA.\n* Use of monoamine oxidase inhibitors in the past month.\n* Current use of Type 1C antiarrhythmics propafenone and flecainide.'}, 'identificationModule': {'nctId': 'NCT00000451', 'briefTitle': 'Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives', 'orgStudyIdInfo': {'id': 'NIAAAOMA12028'}, 'secondaryIdInfos': [{'id': 'R01AA012028', 'link': 'https://reporter.nih.gov/quickSearch/R01AA012028', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Naltrexone plus Sertraline', 'interventionNames': ['Drug: naltrexone']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Naltrexone alone', 'interventionNames': ['Drug: sertraline', 'Drug: naltrexone']}], 'interventions': [{'name': 'sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': '16 week outpatient study', 'armGroupLabels': ['2']}, {'name': 'naltrexone', 'type': 'DRUG', 'otherNames': ['Revia'], 'description': '16 week outpatient study', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': "Dr. Stephanie O'Malley", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}]}}}