Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
This study has been completed.
Sponsor:
Lisa Cox, PhD
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
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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:
Genetics Home Reference related topics:
bladder cancer
MedlinePlus related topics:
Bladder Cancer
Cancer
Cervical Cancer
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Quitting Smoking
Smoking
Stomach Cancer
U.S. FDA Resources
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
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 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 May 22, 2013