Nctid:
NCT00000450
Payload:
{"FullStudy"=>{"Rank"=>498876, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000437", "ConditionMeshTerm"=>"Alcoholism"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019973", "ConditionAncestorTerm"=>"Alcohol-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3783", "ConditionBrowseLeafName"=>"Alcoholism", "ConditionBrowseLeafAsFound"=>"Alcoholism", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21842", "ConditionBrowseLeafName"=>"Alcohol-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21837", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M30302", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000009271", "InterventionMeshTerm"=>"Naltrexone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000427", "InterventionAncestorTerm"=>"Alcohol Deterrents"}, {"InterventionAncestorId"=>"D000009292", "InterventionAncestorTerm"=>"Narcotic Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12222", "InterventionBrowseLeafName"=>"Naltrexone", "InterventionBrowseLeafAsFound"=>"General anesthesia", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M268823", "InterventionBrowseLeafName"=>"Nalmefene", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3777", "InterventionBrowseLeafName"=>"Ethanol", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12245", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12243", "InterventionBrowseLeafName"=>"Narcotic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Alcohol Deterrents", "InterventionBrowseBranchAbbrev"=>"AlcDet"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Quadruple", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider", "Investigator", "Outcomes Assessor"]}, "DesignMaskingDescription"=>"Naltrexone and placebo were identical in appearance and packaging to preserve the double blind."}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Sequential Assignment", "DesignInterventionModelDescription"=>"Naltrexone 50 mg was provided for 3 months to all study participants, who were masked regarding the identity of study medication. At 3 months, full and partial responders were randomized to an additional 9 months of double blind treatment with naltrexone or matched placebo. Full responders were defined as complete abstinence for the last six weeks of the acute phase. Partial responders were defined as having no more than 2 heavy drinking days in any given week and/or a 50% reduction in weekly alcohol consumption from baseline over the last six weeks of the acute phase."}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"159"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 10, 1997", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2017", "CompletionDateStruct"=>{"CompletionDate"=>"February 13, 2002", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"April 18, 2017", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 20, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"February 13, 2002", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{"OversightHasDMC"=>"No", "IsFDARegulatedDrug"=>"Yes", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Alcoholism"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"65 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMeets criteria for alcohol dependence.\nExpresses a desire to cut down or stop drinking.\n\nExclusion Criteria:\n\nCurrently meets criteria for dependence on substances other than alcohol.\nHistory of opiate dependence or evidence of current opiate use.\nSignificant medical disorders that will increase potential risk or interfere with study participation.\nLiver function tests more than 3 times normal or elevated bilirubin.\nFemale patients who are pregnant, nursing, or not using a reliable method of birth control.\nInability to understand and provide a consent form.\nTreatment with an investigational drug during the previous month.\nPrior treatment with naltrexone.\nChronic treatment with any narcotic-containing medications during the previous month.\nSensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.\nCurrent treatment with disulfiram.\nMore than 6 weeks of abstinence.\nMeets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy."}, "IdentificationModule"=>{"NCTId"=>"NCT00000450", "BriefTitle"=>"Naltrexone Maintenance Treatment of Alcoholism", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"The Scripps Research Institute"}, "OfficialTitle"=>"Nalmefene Maintenance Treatment of Alcoholism", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIAAAMAS10518"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AA010518", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AA010518", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Naltrexone Tablet", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Naltrexone Tablet"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Matched Placebo Tablet", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Matched Placebo Tablet"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Naltrexone Tablet", "InterventionType"=>"Drug", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Revia"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Naltrexone Tablet"]}}, {"InterventionName"=>"Matched Placebo Tablet", "InterventionType"=>"Drug", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Placebo"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Matched Placebo Tablet"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"33136", "LocationCity"=>"Miami", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Psychiatry, University of Miami School of Medicine"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Barbara Mason, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"The Scripps Research Institute"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"No"}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"The Scripps Research Institute", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Principal Investigator", "ResponsiblePartyInvestigatorFullName"=>"Barbara J. Mason", "ResponsiblePartyInvestigatorAffiliation"=>"The Scripps Research Institute"}}}}}}
