Nctid:
NCT00000446
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000437", "term"=>"Alcoholism"}, {"id"=>"D000040921", "term"=>"Stress Disorders, Traumatic"}, {"id"=>"D000013313", "term"=>"Stress Disorders, Post-Traumatic"}], "ancestors"=>[{"id"=>"D000068099", "term"=>"Trauma and Stressor Related Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}], "browseLeaves"=>[{"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcoholism", "relevance"=>"HIGH"}, {"id"=>"M24916", "name"=>"Stress Disorders, Traumatic", "asFound"=>"Traumatic Stress Disorder", "relevance"=>"HIGH"}, {"id"=>"M16103", "name"=>"Stress Disorders, Post-Traumatic", "asFound"=>"Post Traumatic Stress Disorder", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M222", "name"=>"Trauma and Stressor Related Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M21842", "name"=>"Alcohol-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000020280", "term"=>"Sertraline"}], "ancestors"=>[{"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000018490", "term"=>"Serotonin Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M22100", "name"=>"Sertraline", "asFound"=>"Occur", "relevance"=>"HIGH"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M19649", "name"=>"Selective Serotonin Reuptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-04", "completionDateStruct"=>{"date"=>"2000-12"}, "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["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"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder.\n* Laboratory tests for blood and urinalysis must be within normal limits.\n* Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions.\n* Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal.\n\nExclusion Criteria:\n\n* Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days.\n* Currently suicidal.\n* Medical reasons not to receive drug therapy.\n* Allergy or hypersensitivity to selective serotonin inhibitor antidepressants.\n* Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease.\n* Liver function test greater than 2 times the normal level\n* Require ongoing therapy with another psychoactive drug during the study period.\n* Females who are pregnant or lactating."}, "identificationModule"=>{"nctId"=>"NCT00000446", "briefTitle"=>"Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "officialTitle"=>"Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism", "orgStudyIdInfo"=>{"id"=>"NIAAABRA10761"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"sertraline (Zoloft)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"29425", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Department of Psychiatry and Behavioral Science, Medical University of South Carolina", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}}}}