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

Lung Cancer Clinical Trial

Official title:

Enhancing Tobacco Use Treatment for African American Light Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666978
• Other study ID #: 10332
• Secondary ID: R01CA091912KUMC-
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: October 11, 2017
• Start date: December 2007
• Est. completion date: June 2010

Study information

• Verified date: October 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Tobacco Use Disorder
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• smoking cessation intervention

Drug:
• bupropion hydrochloride

Genetic:
• gene expression analysis

• polymerase chain reaction

Other:
• counseling intervention

• educational intervention

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Swope Health Central	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Lisa Sanderson Cox, PhD	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 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	Number of Slow and Fast Metabolizers by Metabolite Ratio	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
Secondary	Number of Participants for Each CYP2B6 Allele	We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.	Week 3
Secondary	Number of Slow and Fast Metabolizers by Genotype	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