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Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of Kansas
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00666978
  Purpose

RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking.

PURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.


Condition Intervention
Bladder Cancer
Cancer-Related Problem/Condition
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Drug: bupropion hydrochloride
Procedure: counseling
Procedure: educational intervention
Procedure: gene expression analysis
Procedure: laboratory biomarker analysis
Procedure: liquid chromatography
Procedure: mass spectrometry
Procedure: polymerase chain reaction
Procedure: polymorphism analysis
Procedure: psychosocial assessment and care
Procedure: questionnaire administration
Procedure: smoking cessation intervention
Procedure: study of socioeconomic and demographic variables

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Liver Cancer Lung Cancer Pancreatic Cancer Quitting Smoking Smoking Stomach Cancer
Drug Information available for: Bupropion hydrochloride Bupropion
U.S. FDA Resources
Study Type: Observational
Official Title: Enhancing Tobacco Use Treatment for African American Light Smokers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterization of CYP2A6 activity, in terms of genotype and phenotype [ Designated as safety issue: No ]
  • Relationship between CYP2A6 activity and smoking cessation outcomes [ Designated as safety issue: No ]
  • CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism [ Designated as safety issue: No ]
  • Nicotine metabolism phenotype of 3'hydroxycotinine/cotinine ratio (3HC/COT) as measured by cotinine and metabolite levels at baseline [ Designated as safety issue: No ]
  • Relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes [ Designated as safety issue: No ]
  • CYP2A6 as a predictor of smoking cessation outcomes [ Designated as safety issue: No ]
  • Characterization of CYP2B6 activity, in terms of genotype and phenotype [ Designated as safety issue: No ]
  • Relationship between CYP2B6 activity and smoking cessation outcomes [ Designated as safety issue: No ]
  • Identification of a bupropion hydrochloride metabolism phenotype as measured by steady state bupropion hydrochloride and metabolite levels [ Designated as safety issue: No ]
  • Relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes [ Designated as safety issue: No ]
  • Relationship between CYP2B6 genetic polymorphisms and blood levels of bupropion hydrochloride and active metabolites [ Designated as safety issue: No ]
  • CYP2B6 genotype as a predictor of smoking cessation outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: December 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month

    • Not a heavy smoker
    • No other forms of tobacco within the past 30 days
  • Must be interested in stopping smoking
  • No other smoker in the household enrolled in this study

PATIENT CHARACTERISTICS:

  • Has a home address and a functioning telephone number
  • Not planning to move from the Kansas City metro area within the next 12 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • No alcohol or substance abuse within the past year
  • Not currently drinking ≥ 14 alcoholic drinks per week
  • No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month
  • No history of seizures or head trauma
  • No history of bulimia or anorexia nervosa
  • No myocardial infarction within the past 30 days
  • No reported use of opiates, cocaine, or stimulants
  • No diabetes requiring oral hypoglycemics or insulin

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
  • No other concurrent medication that contains bupropion hydrochloride
  • No concurrent psychoactive medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666978

Locations
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Missouri
Swope Health Central Recruiting
Kansas City, Missouri, United States, 64130
Contact: Contact Person     816-627-2122        
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Lisa S. Cox, PhD University of Kansas
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000581423, KUMC-HSC-10332, KUMC-070313
Study First Received: April 24, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00666978  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
bladder cancer
cervical cancer
esophageal cancer
gastric cancer
renal cell carcinoma
adult primary liver cancer
non-small cell lung cancer
small cell lung cancer
pancreatic cancer
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
adult acute myeloid leukemia
tobacco use disorder

Study placed in the following topic categories:
Thoracic Neoplasms
Liver Diseases
Pancreatic Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Smoking
Dopamine
Lung Neoplasms
Oral cancer
Laryngeal carcinoma
Acute myeloid leukemia, adult
Kidney Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Tobacco Use Disorder
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Acute myelogenous leukemia
Endocrine System Diseases
Stomach cancer
Renal cancer
Leukemia, Myeloid
Lip and oral cavity cancer
Carcinoma
Carcinoma, Small Cell
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Esophageal Diseases

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Respiratory Tract Neoplasms
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009