Nctid:
NCT00000440
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"}], "browseLeaves"=>[{"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcoholism", "relevance"=>"HIGH"}, {"id"=>"M21842", "name"=>"Alcohol-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D009271", "term"=>"Naltrexone"}, {"id"=>"D020280", "term"=>"Sertraline"}], "ancestors"=>[{"id"=>"D000427", "term"=>"Alcohol Deterrents"}, {"id"=>"D009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000928", "term"=>"Antidepressive Agents"}, {"id"=>"D011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D018490", "term"=>"Serotonin Agents"}], "browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M22100", "name"=>"Sertraline", "asFound"=>"Pro", "relevance"=>"HIGH"}, {"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"/week", "relevance"=>"HIGH"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}, {"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"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>124}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-11", "completionDateStruct"=>{"date"=>"2002-09"}, "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"]}, "descriptionModule"=>{"briefSummary"=>"This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets the criteria for alcohol dependence.\n* Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.\n* Able to read English and complete study evaluations.\n* A stable residence and a telephone to ensure that subjects can be located during the study.\n\nExclusion Criteria:\n\n* Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.\n* Current use of disulfiram (Antabuse) or a MAO Inhibitor.\n* Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).\n* Major depression at the time of assessment.\n* Previous treatment with naltrexone (Revia) for alcohol dependence.\n* Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.\n* Abstinent longer than 30 days prior to admission to program.\n* Hepatocellular disease or elevated bilirubin levels.\n* Females who are pregnant, nursing, or not using a reliable method of birth control."}, "identificationModule"=>{"nctId"=>"NCT00000440", "briefTitle"=>"Sertraline and Naltrexone for Alcohol Dependence", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "officialTitle"=>"Sertraline and Naltrexone for Alcohol Dependents", "orgStudyIdInfo"=>{"id"=>"NIAAAFAR11222"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"naltrexone (Revia)", "type"=>"DRUG"}, {"name"=>"sertraline (Zoloft)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Department of Psychiatry, Mount Sinai School of Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}}}}
