Nctid:
NCT00000289
Payload:
{"FullStudy"=>{"Rank"=>499033, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014029", "ConditionMeshTerm"=>"Tobacco Use Disorder"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16785", "ConditionBrowseLeafName"=>"Tobacco Use Disorder", "ConditionBrowseLeafAsFound"=>"Tobacco Use Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21837", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M30302", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000017294", "InterventionMeshTerm"=>"Ondansetron"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000932", "InterventionAncestorTerm"=>"Antiemetics"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000005765", "InterventionAncestorTerm"=>"Gastrointestinal Agents"}, {"InterventionAncestorId"=>"D000000982", "InterventionAncestorTerm"=>"Antipruritics"}, {"InterventionAncestorId"=>"D000003879", "InterventionAncestorTerm"=>"Dermatologic Agents"}, {"InterventionAncestorId"=>"D000058831", "InterventionAncestorTerm"=>"Serotonin 5-HT3 Receptor Antagonists"}, {"InterventionAncestorId"=>"D000012702", "InterventionAncestorTerm"=>"Serotonin Antagonists"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12478", "InterventionBrowseLeafName"=>"Nicotine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19588", "InterventionBrowseLeafName"=>"Ondansetron", "InterventionBrowseLeafAsFound"=>"Antigen", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4251", "InterventionBrowseLeafName"=>"Antiemetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8881", "InterventionBrowseLeafName"=>"Gastrointestinal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7074", "InterventionBrowseLeafName"=>"Dermatologic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29246", "InterventionBrowseLeafName"=>"Serotonin 5-HT3 Receptor Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antiemetics", "InterventionBrowseBranchAbbrev"=>"AnEm"}, {"InterventionBrowseBranchName"=>"Dermatologic Agents", "InterventionBrowseBranchAbbrev"=>"Derm"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"0"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1998"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 1998", "CompletionDateStruct"=>{"CompletionDate"=>"December 2001"}, "LastUpdateSubmitDate"=>"January 11, 2017", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 12, 2017", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Subjective effects"}, {"PrimaryOutcomeMeasure"=>"Physiological effects"}, {"PrimaryOutcomeMeasure"=>"Performance effects"}]}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Tobacco Use Disorder"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.", "DetailedDescription"=>"Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the beneficial effects of the nicotine patch in redugin withdrawal symptoms. Studies have also shown that cotinine enhances serotonin levels. This study examined the effects of several doses of a 5HT3 antagonist, ondanstron, in combination with the nicotine patch. This medication has been observed to reduce nicotine withdrawal symptoms in rats. These effects were compared to the nicotine patch alone. The results of this study produced some modest effects showing that the 8mg dose of ondansetron suppressed tobacco withdrawal symptoms to a greater extent than the nicotine patch alone."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"45 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMale/Female subjects ages 21-45 years inclusive, with a smoking history of at least 15 cigarettes daily (greater than or equal to 50) for at least 1 yr. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence.\n\nExclusion Criteria:\n\nHistory of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug (more than 3 drinks per day or 21 drinks per wk). use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychiatric illness (less than 1yr since last episode of major depressive episode)."}, "IdentificationModule"=>{"NCTId"=>"NCT00000289", "BriefTitle"=>"Role of Metabolites in Nicotine Dependence (3) - 6", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Drug Abuse (NIDA)"}, "OfficialTitle"=>"Role of Metabolites in Nicotine Dependence (3)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIDA-09259-6"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P50-09259-6"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Ondansetron", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"55455", "LocationCity"=>"Minneapolis", "LocationState"=>"Minnesota", "LocationCountry"=>"United States", "LocationFacility"=>"University of Minnesota"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Dorothy Hatsukami, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Minnesota"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Drug Abuse (NIDA)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"University of Minnesota", "CollaboratorClass"=>"OTHER"}]}}}}}}
