Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking - Full Text View

Sponsor:	University of Kansas
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Kansas
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 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	Behavioral: smoking cessation intervention Drug: bupropion hydrochloride
Group 2	Genetic: gene expression analysis Genetic: polymerase chain reaction Other: counseling intervention
Group 3	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

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

University of Kansas

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lisa S. Cox, PhD

University of Kansas

More Information

Additional Information:

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

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cox LS, Faseru B, Mayo MS, Krebill R, Snow TS, Bronars CA, Nollen NL, Choi WS, Okuyemi KS, Salzman GA, Benowitz NL, Tyndale RF, Ahluwalia JS. Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data. Trials. 2011 Jan 25;12:22.

Responsible Party:	Lisa S. Cox, PhD, University of Kansas Medical Center
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:	December 18, 2010
Health Authority:	United States:Human Subjects Committee

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 Diseases
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 Diseases

ClinicalTrials.gov processed this record on February 09, 2012