Nctid:
NCT00000442
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"}], "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"}], "browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"/week", "relevance"=>"HIGH"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>57}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2011-06", "completionDateStruct"=>{"date"=>"2002-12"}, "lastUpdateSubmitDate"=>"2011-06-17", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2011-06-20", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Alcoholism"]}, "descriptionModule"=>{"briefSummary"=>"This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for alcohol dependence.\n* Abstinent from alcohol for a period of at least 3 days prior to beginning of study.\n* Able to read English and complete study evaluations.\n* Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.\n\nExclusion Criteria:\n\n* Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.\n* Prior history of opioid dependence.\n* Regular use of psychoactive drugs including anxiolytics and antidepressants.\n* Prior treatment with naltrexone.\n* Current use of disulfiram.\n* Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).\n* Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.\n* Abstinent longer than 28 days prior to randomization."}, "identificationModule"=>{"nctId"=>"NCT00000442", "briefTitle"=>"Naltrexone for Relapse Prevention", "organization"=>{"class"=>"OTHER", "fullName"=>"UConn Health"}, "officialTitle"=>"Etiology and Treatment of Alcohol Dependence", "orgStudyIdInfo"=>{"id"=>"NIAAAKRA3510"}, "secondaryIdInfos"=>[{"id"=>"P50AA003510", "link"=>"https://reporter.nih.gov/quickSearch/P50AA003510", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"naltrexone (Revia)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"19103", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Department of Psychiatry, University of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"UConn Health", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}], "responsibleParty"=>{"oldNameTitle"=>"Henry Kranzler", "oldOrganization"=>"University of Pennsylvania"}}}}
