Nctid:
NCT00000437
Payload:
{"FullStudy"=>{"Rank"=>498889, "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"}, {"InterventionMeshId"=>"D000009538", "InterventionMeshTerm"=>"Nicotine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000005731", "InterventionAncestorTerm"=>"Ganglionic Stimulants"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018722", "InterventionAncestorTerm"=>"Nicotinic Agonists"}, {"InterventionAncestorId"=>"D000018679", "InterventionAncestorTerm"=>"Cholinergic Agonists"}, {"InterventionAncestorId"=>"D000018678", "InterventionAncestorTerm"=>"Cholinergic Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000000427", "InterventionAncestorTerm"=>"Alcohol Deterrents"}, {"InterventionAncestorId"=>"D000009292", "InterventionAncestorTerm"=>"Narcotic Antagonists"}, {"InterventionAncestorId"=>"D000018689", "InterventionAncestorTerm"=>"Sensory System Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12478", "InterventionBrowseLeafName"=>"Nicotine", "InterventionBrowseLeafAsFound"=>"Complete", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3777", "InterventionBrowseLeafName"=>"Ethanol", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12222", "InterventionBrowseLeafName"=>"Naltrexone", "InterventionBrowseLeafAsFound"=>"General anesthesia", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M268823", "InterventionBrowseLeafName"=>"Nalmefene", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4029", "InterventionBrowseLeafName"=>"Central Nervous System Stimulants", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20796", "InterventionBrowseLeafName"=>"Nicotinic Agonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20758", "InterventionBrowseLeafName"=>"Cholinergic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12245", "InterventionBrowseLeafName"=>"Narcotics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M12243", "InterventionBrowseLeafName"=>"Narcotic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Alcohol Deterrents", "InterventionBrowseBranchAbbrev"=>"AlcDet"}, {"InterventionBrowseBranchName"=>"Narcotic Antagonists", "InterventionBrowseBranchAbbrev"=>"NarcAntag"}, {"InterventionBrowseBranchName"=>"Central Nervous System Stimulants", "InterventionBrowseBranchAbbrev"=>"CNSSti"}, {"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"=>"Double blind tablet and patch active study medications, and matched tablet and patch placebos"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"60"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 26, 1997", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2017", "CompletionDateStruct"=>{"CompletionDate"=>"September 15, 2005", "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"=>"September 15, 2005", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{"IsUSExport"=>"No", "OversightHasDMC"=>"No", "IsFDARegulatedDrug"=>"Yes", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Alcoholism", "Smoking"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.", "DetailedDescription"=>"Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms."}, "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 and nicotine dependence.\nExpresses a desire to cut down or stop drinking and smoking.\n\nExclusion Criteria:\n\nCurrently meets criteria for dependence on substances other than alcohol and nicotine.\nAny history 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.\nFemales who are pregnant, nursing, or not using a reliable method of birth control.\nMeets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.\nInability to understand and/or comply with the provisions of the protocol and consent form.\nTreatment with an investigational drug during the previous month.\nChronic treatment with any narcotic-containing medications during the previous month.\nSensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.\nCurrent treatment with disulfiram (Antabuse) or nicotine replacement therapy.\nMore than 6 weeks of abstinence."}, "IdentificationModule"=>{"NCTId"=>"NCT00000437", "BriefTitle"=>"Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"The Scripps Research Institute"}, "OfficialTitle"=>"Nalmefene in Nicotine and Alcohol Dependence", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIAAAMAS11210"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AA011210", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AA011210", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Naltrexone Tablet and Nicotine Patch", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Naltrexone Tablet and Nicotine Patch"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Naltrexone Tablet and Placebo Patch", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Naltrexone Tablet and Placebo Patch"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Placebo Tablet and Nicotine Patch", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Placebo Tablet and Nicotine Patch"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Placebo Tablet and Placebo Patch", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Placebo Tablet and Placebo Patch"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Naltrexone Tablet and Nicotine Patch", "InterventionType"=>"Drug", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Revia and Nicotrol"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Naltrexone Tablet and Nicotine Patch"]}}, {"InterventionName"=>"Naltrexone Tablet and Placebo Patch", "InterventionType"=>"Drug", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Revia"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Naltrexone Tablet and Placebo Patch"]}}, {"InterventionName"=>"Placebo Tablet and Nicotine Patch", "InterventionType"=>"Drug", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Nicotrol"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo Tablet and Nicotine Patch"]}}, {"InterventionName"=>"Placebo Tablet and Placebo Patch", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Placebo Tablet and Placebo Patch"]}}]}}, "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, PhD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Miam"}]}}, "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"}}}}}}
