Nctid:
NCT00000452
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "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"=>"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"=>"D000009271", "term"=>"Naltrexone"}], "ancestors"=>[{"id"=>"D000000427", "term"=>"Alcohol Deterrents"}, {"id"=>"D000009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"3D", "relevance"=>"HIGH"}, {"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>240}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-11", "completionDateStruct"=>{"date"=>"2003-01"}, "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"]}, "descriptionModule"=>{"briefSummary"=>"The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for current diagnosis of alcohol dependence.\n* Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days.\n* Successful completion of medical detoxification.\n* Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits.\n* Understands and signs the informed consent.\n\nExclusion Criteria:\n\n* Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana.\n* Evidence of opiate use in the past 30 days.\n* Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification).\n* History of unstable or serious medical illness, including need for opioid analgesics.\n* Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms.\n* Use of an investigation medication in the past 30 days.\n* Female subjects who are pregnant, nursing, or not using reliable method of contraception."}, "identificationModule"=>{"nctId"=>"NCT00000452", "briefTitle"=>"Naltrexone Treatment of Alcohol Dependence", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)"}, "orgStudyIdInfo"=>{"id"=>"NIAAAVOL07517"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"naltrexone (Revia)", "type"=>"DRUG"}, {"name"=>"Compliance Enhancement Tech.", "type"=>"BEHAVIORAL"}, {"name"=>"Cognitive Behavior Therapy", "type"=>"BEHAVIORAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Treatment Research Center, University of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}}}}
