Nctid:
NCT00000447
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000437", "term"=>"Alcoholism"}, {"id"=>"D000014029", "term"=>"Tobacco Use Disorder"}], "ancestors"=>[{"id"=>"D000019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M3783", "name"=>"Alcoholism", "asFound"=>"Alcoholism", "relevance"=>"HIGH"}, {"id"=>"M16785", "name"=>"Tobacco Use Disorder", "asFound"=>"Nicotine Dependence", "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"=>"D000009271", "term"=>"Naltrexone"}, {"id"=>"D000009538", "term"=>"Nicotine"}], "ancestors"=>[{"id"=>"D000005731", "term"=>"Ganglionic Stimulants"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018722", "term"=>"Nicotinic Agonists"}, {"id"=>"D000018679", "term"=>"Cholinergic Agonists"}, {"id"=>"D000018678", "term"=>"Cholinergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000427", "term"=>"Alcohol Deterrents"}, {"id"=>"D000009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}], "browseLeaves"=>[{"id"=>"M12478", "name"=>"Nicotine", "asFound"=>"Assess", "relevance"=>"HIGH"}, {"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M12222", "name"=>"Naltrexone", "asFound"=>"Lumbar", "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"=>"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"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"FACTORIAL"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-09", "completionDateStruct"=>{"date"=>"2003-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2010-09-30", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2010-10-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Alcoholism", "Smoking"]}, "descriptionModule"=>{"briefSummary"=>"This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Meets criteria for alcohol and nicotine dependence.\n* Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.\n* Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.\n* Motivated to quit smoking.\n* Willing and able to participate in the 12 week outpatient treatment.\n* Acceptable health.\n* Able to provide a collateral informant.\n* Willing to be followed for 6 months after treatment ends.\n* Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.\n\nExclusion Criteria:\n\n* Current diagnosis of dependence on other substances except nicotine and alcohol.\n* Having moderately severe or severe alcohol withdrawal symptoms.\n* Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).\n* History of opioid abuse.\n* Recent use of cocaine.\n* Not desiring to quit smoking.\n* Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.\n* History of psychosis.\n* Current suicidality, homicidally or psychiatric symptoms requiring other medications.\n* Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.\n* Current treatment with psychotropic medications.\n* Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment."}, "identificationModule"=>{"nctId"=>"NCT00000447", "briefTitle"=>"Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)", "organization"=>{"class"=>"OTHER", "fullName"=>"The University of Texas Health Science Center, Houston"}, "officialTitle"=>"Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence", "orgStudyIdInfo"=>{"id"=>"NIAAA-SCHMITZ-11216-04"}, "secondaryIdInfos"=>[{"id"=>"R01AA011216", "link"=>"https://reporter.nih.gov/quickSearch/R01AA011216", "type"=>"NIH"}, {"id"=>"NIH Grant 5R01AA011216-04"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"naltrexone (Revia)", "type"=>"DRUG"}, {"name"=>"nicotine replacement patch", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"Joy Schmitz", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The University of Texas Health Science Center, Houston"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The University of Texas Health Science Center, Houston", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Alcohol Abuse and Alcoholism (NIAAA)", "class"=>"NIH"}]}}}