Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Behavioral study, Biomarker/Laboratory analysis, Educational/Counseling/Training, Prevention Active 18 and over NCI KUMC-HSC-10332 10332, KUMC-070313, NCT00666978

Objectives

Primary

1. 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

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

Tertiary

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

Entry 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

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

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

Expected Enrollment

Outcomes

Efficacy

Characterization of CYP2A6 activity, in terms of genotype and phenotype
Relationship between CYP2A6 activity and smoking cessation outcomes
CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism
Nicotine metabolism phenotype of 3’hydroxycotinine/cotinine ratio (3HC/COT) as measured by cotinine and metabolite levels at baseline
Relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes
CYP2A6 as a predictor of smoking cessation outcomes
Characterization of CYP2B6 activity, in terms of genotype and phenotype
Relationship between CYP2B6 activity and smoking cessation outcomes
Identification of a bupropion hydrochloride metabolism phenotype as measured by steady state bupropion hydrochloride and metabolite levels
Relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes
Relationship between CYP2B6 genetic polymorphisms and blood levels of bupropion hydrochloride and active metabolites
CYP2B6 genotype as a predictor 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.

Trial Contact Information

Trial Lead Organizations

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Lisa Cox, PhD, Principal investigator		Ph: 913-588-2643 Email: lcox@kumc.edu

U.S.A.
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
Missouri
	Kansas City
	Swope Health Central
		Contact Person	Ph:  816-627-2122

Registry Information
Official Title		Enhancing Tobacco Use Treatment for African American Light Smokers
Trial Start Date		2007-12-17
Trial Completion Date		2009-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00666978
Date Submitted to PDQ		2008-01-04
Information Last Verified		2008-12-21
NCI Grant/Contract Number		CA091912