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

October 11, 2017 updated by: Lisa Sanderson Cox, PhD

Enhancing Tobacco Use Treatment for African American Light Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers.

Secondary

  • To characterize CYP2A6 activity in African Americans who are light smokers by evaluating phenotype (3'hydroxycotinine/cotinine ratio [3HC/COT]) and CYP2A6 genotype.
  • To evaluate the relationship between CYP2A6 activity and smoking cessation outcomes.
  • To evaluate CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism in African Americans who are light smokers.
  • To measure baseline cotinine and metabolite levels to evaluate the nicotine metabolism phenotype of 3HC/COT.
  • To evaluate the relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes.
  • To evaluate CYP2A6 genotype as a predictor of smoking cessation outcomes.

Tertiary

  • To characterize CYP2B6 activity in African Americans who are light smokers by evaluating phenotype and CYP2B6 genotype.
  • To evaluate the relationship between CYP2B6 activity and smoking cessation outcomes.
  • To measure steady state bupropion hydrochloride and metabolite levels to identify a bupropion metabolism phenotype.
  • To evaluate the relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes.
  • To evaluate the relationship between CYP2B6 genetic polymorphisms (genotype) and blood levels of bupropion hydrochloride and active metabolites (phenotype).
  • To determine the effects of CYP2B6 genotype as predictors of smoking cessation outcomes.

OUTLINE: Participants are randomized to one of two arms.

  • Arm I: Participants receive oral bupropion hydrochloride once or twice daily in weeks 0-6. Participants also undergo 6 sessions of health education counseling conducted in person during clinic visits in weeks 0, 3, and 7 and via telephone in weeks 1, 5, and 16. The health education counseling sessions include providing information about the risks of continued smoking and the benefits of quitting, developing a quit plan, outlining a concrete quit day preparation plan, discussing strategies for successful quitting, building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers to abstinence, and using medication for smoking cessation. Participants receive Kick It at Swope: Stop Smoking Guide, a culturally-sensitive smoking cessation guide, to review with their study counselor during the first counseling session.
  • Arm II: Participants receive an oral placebo once or twice daily in weeks 0-6. Participants also undergo health education counseling as in arm I.

Participants complete baseline questionnaires about demographics, smoking history, and psychometrics, including the following: racial identity, depressive symptoms, alcohol use, stress, smoking consequences, social support, environmental influences of smoking, adherence to study medication, nicotine withdrawal, craving, and mood.

Participants undergo serum sample collection in weeks 0 and 3. To standardize the time since the last cigarette, participants are asked to smoke one cigarette prior to serum sample collection in week 0. Samples are analyzed for nicotine metabolism phenotype and bupropion hydrochloride metabolism phenotype by liquid chromatography and mass spectrometry and CYP2A6 and CYP2B6 genotype by polymerase chain reaction and polymorphism analysis. Participants who self-report abstinence also undergo saliva sample collection in weeks 7 and 26 to measure cotinine levels to verify smoking status.

After completion of study intervention, participants are followed at 6 months.

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64130
        • Swope Health Central

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupropion Arm
Subjects undergo smoking cessation intervention and take bupropion.
Genetic: gene expression analysis
Procedure: psychosocial assessment and care
Other: educational intervention
Other: counseling intervention
Genetic: polymerase chain reaction
Behavioral: smoking cessation intervention
Drug: bupropion hydrochloride
Placebo Comparator: Health Education Arm
Subjects receive counseling intervention and take placebo.
Genetic: gene expression analysis
Procedure: psychosocial assessment and care
Other: educational intervention
Other: counseling intervention
Genetic: polymerase chain reaction
Behavioral: smoking cessation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 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.
Week 3
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.
Week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Sanderson Cox, PhD

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa S. Cox, PhD, University of Kansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10332 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • R01CA091912 (U.S. NIH Grant/Contract)
  • KUMC-HSC-10332
  • KUMC-070313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on gene expression analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe