Nctid:
NCT00000437
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"}, {"id"=>"D009538", "term"=>"Nicotine"}], "ancestors"=>[{"id"=>"D005731", "term"=>"Ganglionic Stimulants"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018722", "term"=>"Nicotinic Agonists"}, {"id"=>"D018679", "term"=>"Cholinergic Agonists"}, {"id"=>"D018678", "term"=>"Cholinergic Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000427", "term"=>"Alcohol Deterrents"}, {"id"=>"D009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}], "browseLeaves"=>[{"id"=>"M268823", "name"=>"Nalmefene", "relevance"=>"LOW"}, {"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M12478", "name"=>"Nicotine", "asFound"=>"Dietary Supplement", "relevance"=>"HIGH"}, {"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"Telephone", "relevance"=>"HIGH"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}, {"id"=>"M20796", "name"=>"Nicotinic Agonists", "relevance"=>"LOW"}, {"id"=>"M20758", "name"=>"Cholinergic Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"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"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Double blind tablet and patch active study medications, and matched tablet and patch placebos"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-09-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-04", "completionDateStruct"=>{"date"=>"2005-09-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2017-04-18", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2017-04-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-09-15", "type"=>"ACTUAL"}}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Alcoholism", "Smoking"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.", "detailedDescription"=>"Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for alcohol dependence and nicotine dependence.\n* Expresses a desire to cut down or stop drinking and smoking.\n\nExclusion Criteria:\n\n* Currently meets criteria for dependence on substances other than alcohol and nicotine.\n* Any history of opiate dependence or evidence of current opiate use.\n* Significant medical disorders that will increase potential risk or interfere with study participation.\n* Liver function tests more than 3 times normal or elevated bilirubin.\n* Females who are pregnant, nursing, or not using a reliable method of birth control.\n* Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.\n* Inability to understand and/or comply with the provisions of the protocol and consent form.\n* Treatment with an investigational drug during the previous month.\n* Chronic treatment with any narcotic-containing medications during the previous month.\n* Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.\n* Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.\n* More than 6 weeks of abstinence."}, "identificationModule"=>{"nctId"=>"NCT00000437", "briefTitle"=>"Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)", "organization"=>{"class"=>"OTHER", "fullName"=>"The Scripps Research Institute"}, "officialTitle"=>"Nalmefene in Nicotine and Alcohol Dependence", "orgStudyIdInfo"=>{"id"=>"NIAAAMAS11210"}, "secondaryIdInfos"=>[{"id"=>"R01AA011210", "link"=>"https://reporter.nih.gov/quickSearch/R01AA011210", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Naltrexone Tablet and Nicotine Patch", "interventionNames"=>["Drug: Naltrexone Tablet and Nicotine Patch"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Naltrexone Tablet and Placebo Patch", "interventionNames"=>["Drug: Naltrexone Tablet and Placebo Patch"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Placebo Tablet and Nicotine Patch", "interventionNames"=>["Drug: Placebo Tablet and Nicotine Patch"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Tablet and Placebo Patch", "interventionNames"=>["Drug: Placebo Tablet and Placebo Patch"]}], "interventions"=>[{"name"=>"Naltrexone Tablet and Nicotine Patch", "type"=>"DRUG", "otherNames"=>["Revia and Nicotrol"], "armGroupLabels"=>["Naltrexone Tablet and Nicotine Patch"]}, {"name"=>"Naltrexone Tablet and Placebo Patch", "type"=>"DRUG", "otherNames"=>["Revia"], "armGroupLabels"=>["Naltrexone Tablet and Placebo Patch"]}, {"name"=>"Placebo Tablet and Nicotine Patch", "type"=>"DRUG", "otherNames"=>["Nicotrol"], "armGroupLabels"=>["Placebo Tablet and Nicotine Patch"]}, {"name"=>"Placebo Tablet and Placebo Patch", "type"=>"DRUG", "armGroupLabels"=>["Placebo Tablet and Placebo Patch"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Department of Psychiatry, University of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}], "overallOfficials"=>[{"name"=>"Barbara Mason, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Miam"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Scripps Research Institute", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Barbara J. Mason", "investigatorAffiliation"=>"The Scripps Research Institute"}}}}
