Clinical trial NCT00666978
Conditions: Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder
Keywords: 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
Sponsor: Lisa Sanderson Cox, PhD
Start date: 2007-12-01; Completion date: 2010-06-01
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

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.

Arms: arm 1: Subjects undergo smoking cessation intervention and take bupropion. arm 2: Subjects receive counseling intervention and take placebo.
Interventions: intervention 1: smoking cessation intervention intervention 2: bupropion hydrochloride intervention 3: gene expression analysis intervention 4: polymerase chain reaction intervention 5: counseling intervention intervention 6: educational intervention intervention 7: psychosocial assessment and care
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents: