Nctid:
NCT00000454
Payload:
{"FullStudy"=>{"Rank"=>498873, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000437", "ConditionMeshTerm"=>"Alcoholism"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019973", "ConditionAncestorTerm"=>"Alcohol-Related Disorders"}, {"ConditionAncestorId"=>"D000019966", "ConditionAncestorTerm"=>"Substance-Related Disorders"}, {"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3783", "ConditionBrowseLeafName"=>"Alcoholism", "ConditionBrowseLeafAsFound"=>"Alcoholism", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21842", "ConditionBrowseLeafName"=>"Alcohol-Related Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"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"=>"D000009538", "InterventionMeshTerm"=>"Nicotine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000005731", "InterventionAncestorTerm"=>"Ganglionic Stimulants"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018722", "InterventionAncestorTerm"=>"Nicotinic Agonists"}, {"InterventionAncestorId"=>"D000018679", "InterventionAncestorTerm"=>"Cholinergic Agonists"}, {"InterventionAncestorId"=>"D000018678", "InterventionAncestorTerm"=>"Cholinergic Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M12478", "InterventionBrowseLeafName"=>"Nicotine", "InterventionBrowseLeafAsFound"=>"Complete", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4029", "InterventionBrowseLeafName"=>"Central Nervous System Stimulants", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20796", "InterventionBrowseLeafName"=>"Nicotinic Agonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20758", "InterventionBrowseLeafName"=>"Cholinergic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Central Nervous System Stimulants", "InterventionBrowseBranchAbbrev"=>"CNSSti"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"112"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 2010", "CompletionDateStruct"=>{"CompletionDate"=>"August 2002"}, "LastUpdateSubmitDate"=>"May 18, 2010", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 19, 2010", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Alcoholism", "Smoking"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"18072840", "ReferenceType"=>"result", "ReferenceCitation"=>"Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Concurrent brief versus intensive smoking intervention during alcohol dependence treatment. Psychol Addict Behav. 2007 Dec;21(4):570-5. doi: 10.1037/0893-164X.21.4.570."}, {"ReferencePMID"=>"17874878", "ReferenceType"=>"result", "ReferenceCitation"=>"Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Alcohol and tobacco cessation in alcohol-dependent smokers: analysis of real-time reports. Psychol Addict Behav. 2007 Sep;21(3):277-86. doi: 10.1037/0893-164X.21.3.277."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study is designed to increase understanding of the processes that affect the treatment outcome of individuals with both alcohol and nicotine dependence. Treatment outcome methodology will be combined with a computerized self-monitoring methodology to examine the extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare System. Nonveteran women will be recruited from the community and enrolled in the day program. Subjects will be randomly assigned to one of the following two conditions: (1) intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent with alcohol treatment."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMeets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence.\nSmoking at least 10 or more cigarettes per day for the past year.\nSeeking treatment for both alcohol and nicotine dependence.\nMinimum 1 week of alcohol abstinence and substance abuse day treatment attendance.\nWilling to provide names of two individuals who can help locate the subject at follow-up.\nWilling to provide name of one individual who can provide collateral information about alcohol and tobacco use.\n\nExclusion Criteria:\n\nOther substance use disorder meeting criteria for dependence.\nAcute medical or psychiatric disorder requiring inpatient treatment.\nTaking medications known to influence alcohol urges (naltrexone, disulfiram).\nMedical problems that would contraindicate nicotine patch use.\nAllergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems.\nUse of other nicotine products such as cigars, pipes, or smokeless tobacco.\nSevere generalized skin disorder.\nMyocardial infarction within 3 months prior to study entry.\nUnstable angina.\nPregnant or lactating females, or females who are not practicing a medically accepted form of contraception.\nImpaired vision or hearing which would interfere with using a hand-held computer.\nReading ability below fifth grade level.\nLack of reliable transportation to the treatment site, or living more than 1 hour from treatment site.\nHomeless or unstable residence.\nPlan for future admission to residential treatment."}, "IdentificationModule"=>{"NCTId"=>"NCT00000454", "BriefTitle"=>"Smoking Cessation in Alcoholism Treatment", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Yale University"}, "OfficialTitle"=>"Field Study of Smoking Cessation in Alcoholism Treatment", "OrgStudyIdInfo"=>{"OrgStudyId"=>"NIAAACOO11197"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AA011197", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AA011197", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"nicotine replacement patch", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"06516", "LocationCity"=>"West Haven", "LocationState"=>"Connecticut", "LocationCountry"=>"United States", "LocationFacility"=>"Substance Abuse Treatment Center, VA Medical Center"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Yale University", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "CollaboratorClass"=>"NIH"}]}}}}}}
