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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666978
First Posted: April 25, 2008
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lisa Sanderson Cox, PhD, University of Kansas Medical Center
  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 Phase
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 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Enhancing Tobacco Use Treatment for African American Light Smokers

Resource links provided by NLM:


Further study details as provided by Lisa Sanderson Cox, PhD, University of Kansas Medical Center:

Primary Outcome Measures:
  • Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months [ Time Frame: 6 months ]
    Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.


Secondary Outcome Measures:
  • Number of Slow and Fast Metabolizers by Metabolite Ratio [ Time Frame: Weeks 0 ]

    Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.

    The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.

    Blood samples were collected for 3HC/COT ratio at Week 0.


  • Number of Participants for Each CYP2B6 Allele [ Time Frame: Week 3 ]
    We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.

  • Number of Slow and Fast Metabolizers by Genotype [ Time Frame: Week 0 ]

    Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include *17, *20, *23,*27, *35, *9, *2, *25, *26, and *4. The fast metabolizers have none of the variant alleles tested.

    Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are *1/*1 genotype by exclusion.



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)
Arms Assigned Interventions
Experimental: Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
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
Placebo Comparator: Health Education Arm
Subjects receive counseling intervention and take placebo.
Behavioral: smoking cessation intervention Genetic: gene expression analysis Genetic: polymerase chain reaction Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Sanderson Cox, PhD
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lisa S. Cox, PhD University of Kansas
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Sanderson Cox, PhD, Research Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00666978     History of Changes
Other Study ID Numbers: 10332
R01CA091912 ( U.S. NIH Grant/Contract )
KUMC-HSC-10332
KUMC-070313
First Submitted: April 24, 2008
First Posted: April 25, 2008
Results First Submitted: April 17, 2017
Results First Posted: July 24, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017

Keywords provided by Lisa Sanderson Cox, PhD, University of Kansas Medical Center:
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:
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases