Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Cox, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00666978
First received: April 24, 2008
Last updated: October 8, 2012
Last verified: October 2012
  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
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Behavioral: smoking cessation intervention
Drug: bupropion hydrochloride
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Enhancing Tobacco Use Treatment for African American Light Smokers

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Efficacy [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

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

Enrollment: 540
Study Start Date: December 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects undergo smoking cessation intervention and take bupropion.
Behavioral: smoking cessation intervention Drug: bupropion hydrochloride
Group 2
Subjects receive counseling intervention.
Genetic: gene expression analysis Genetic: polymerase chain reaction Other: counseling intervention
Group 3
Subjects receive educational counseling and psychosocial assessment and care.
Other: educational intervention Procedure: psychosocial assessment and care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

African Americans Smokers

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kansas City, Kansas, United States, 66160-7357
United States, Missouri
Swope Health Central
Kansas City, Missouri, United States, 64130
Sponsors and Collaborators
Lisa Cox, PhD
Investigators
Principal Investigator: Lisa S. Cox, PhD University of Kansas
  More Information

Additional Information:
No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Cox, PhD, Research Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00666978     History of Changes
Other Study ID Numbers: 10332, R01CA091912, KUMC-HSC-10332, KUMC-070313
Study First Received: April 24, 2008
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Leukemia
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Tobacco Use Disorder
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014