Nctid:
NCT00000446
Payload:
{"FullStudy"=>{"Rank"=>475162, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000437", "ConditionMeshTerm"=>"Alcoholism"}, {"ConditionMeshId"=>"D000040921", "ConditionMeshTerm"=>"Stress Disorders, Traumatic"}, {"ConditionMeshId"=>"D000013313", "ConditionMeshTerm"=>"Stress Disorders, Post-Traumatic"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000068099", "ConditionAncestorTerm"=>"Trauma and Stressor Related Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000019973", "ConditionAncestorTerm"=>"Alcohol-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M24606", "ConditionBrowseLeafName"=>"Stress Disorders, Traumatic", "ConditionBrowseLeafAsFound"=>"Traumatic Stress Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15793", "ConditionBrowseLeafName"=>"Stress Disorders, Post-Traumatic", "ConditionBrowseLeafAsFound"=>"Post Traumatic Stress Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3473", "ConditionBrowseLeafName"=>"Alcoholism", "ConditionBrowseLeafAsFound"=>"Alcoholism", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17375", "ConditionBrowseLeafName"=>"Wounds and Injuries", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M222", "ConditionBrowseLeafName"=>"Trauma and Stressor Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21532", "ConditionBrowseLeafName"=>"Alcohol-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21527", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M29992", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Wounds and Injuries", "ConditionBrowseBranchAbbrev"=>"BC26"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000020280", "InterventionMeshTerm"=>"Sertraline"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000017367", "InterventionAncestorTerm"=>"Selective Serotonin Reuptake Inhibitors"}, {"InterventionAncestorId"=>"D000014179", "InterventionAncestorTerm"=>"Neurotransmitter Uptake Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21790", "InterventionBrowseLeafName"=>"Sertraline", "InterventionBrowseLeafAsFound"=>"Hepatocellular", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3937", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14164", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15202", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19339", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20194", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2004", "CompletionDateStruct"=>{"CompletionDate"=>"December 2000"}, "LastUpdateSubmitDate"=>"June 23, 2005", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 24, 2005", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Alcoholism", "Post-Traumatic Stress Disorder"]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial.\n\nAll subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMeets criteria for alcohol abuse or dependence and post-traumatic stress disorder.\nLaboratory tests for blood and urinalysis must be within normal limits.\nMust be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.\nFemales who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.\n\nExclusion Criteria:\n\nHave a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.\nCurrently suicidal.\nMedical reasons not to receive drug therapy.\nAllergy or hypersensitivity to selective serotonin inhibitor antidepressants.\nSignificant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.\nLiver function test greater than 2 times the normal level\nRequire ongoing therapy with another psychoactive drug during the study period.\nFemales who are pregnant or lactating."}, "IdentificationModule"=>{"NCTId"=>"NCT00000446", "BriefTitle"=>"Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "OfficialTitle"=>"Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIAAABRA10761"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"sertraline (Zoloft)", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"29425", "LocationCity"=>"Charleston", "LocationState"=>"South Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Department of Psychiatry and Behavioral Science, Medical University of South Carolina"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "LeadSponsorClass"=>"NIH"}}}}}}
