Nctid:
NCT00000458
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000437", "term"=>"Alcoholism"}], "ancestors"=>[{"id"=>"D000019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcoholism", "relevance"=>"HIGH"}, {"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "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"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic 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"=>"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"}, "enrollmentInfo"=>{"count"=>100}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-08", "completionDateStruct"=>{"date"=>"2002-01"}, "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", "Depression"]}, "descriptionModule"=>{"briefSummary"=>"This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for major depressive episode.\n* Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.\n* Has had no more than one previous inpatient medical detoxification.\n* Able to maintain sobriety for ten days.\n* Able to read and understand questionnaires and informed consent.\n* Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.\n\nExclusion Criteria:\n\n* Meets criteria for any other psychoactive substance dependence other than nicotine.\n* Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.\n* Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.\n* Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.\n* Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.\n* Current use of disulfiram (Antabuse) or anti-seizure medications.\n* Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.\n* Hepatocellular disease.\n* Females who are pregnant, nursing, or not using a reliable form of birth control.\n* Current charges pending for violent crime (excluding DUI related offenses).\n* Previous adverse experience with a serotonin reuptake inhibitor.\n* Current homicidal or suicidal ideation."}, "identificationModule"=>{"nctId"=>"NCT00000458", "briefTitle"=>"Sertraline and Cognitive Therapy in Depressed Alcoholics", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "officialTitle"=>"Sertraline and Cognitive Therapy in Depressed Alcoholics", "orgStudyIdInfo"=>{"id"=>"NIAAAMOA10476"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"sertraline (Zoloft)", "type"=>"DRUG"}, {"name"=>"cognitive behavior therapy", "type"=>"BEHAVIORAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"29425", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"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"}}}}