Nctid:
NCT00000438
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "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"=>"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"=>"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"=>"M12222", "name"=>"Naltrexone", "asFound"=>"Telephone", "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", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>192}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-05", "completionDateStruct"=>{"date"=>"2003-03"}, "lastUpdateSubmitDate"=>"2010-05-13", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2010-05-14", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "oversightModule"=>{"oversightHasDmc"=>false}, "conditionsModule"=>{"conditions"=>["Alcoholism"]}, "descriptionModule"=>{"briefSummary"=>"This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for alcohol dependence.\n* Committed to alcohol abstinence as a treatment goal.\n* Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.\n\nExclusion Criteria:\n\n* Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).\n* Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.\n* Females who are pregnant, lactating, or not using a reliable method of contraception.\n* Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.\n* Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.\n* Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.\n* Vocabulary below the 5th grade reading level.\n* Abnormal MRI scan.\n* HIV infection due to the neurological sequelae.\n* Significant central nervous system diseases.\n* Seizure disorder or history of closed head trauma.\n* Neuroendocrine disorders.\n* Treatment with opiates within the last six months."}, "identificationModule"=>{"nctId"=>"NCT00000438", "briefTitle"=>"Naltrexone Treatment for Alcoholism", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins University"}, "officialTitle"=>"Naltrexone Treatment for Alcoholism: Predicting Outcome", "orgStudyIdInfo"=>{"id"=>"NIAAAMCC11855"}, "secondaryIdInfos"=>[{"id"=>"R01AA011855", "link"=>"https://reporter.nih.gov/quickSearch/R01AA011855", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"naltrexone (Revia)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hospital", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}], "responsibleParty"=>{"oldNameTitle"=>"Mary E. McCaul, Ph.D., Professor", "oldOrganization"=>"Johns Hopkins University"}}}}
