Clinical trial NCT00666978: Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
Official title: Enhancing Tobacco Use Treatment for African American Light Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-25
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Slow and Fast Metabolizers by Metabolite Ratio
timeFrame: Weeks 0
measure: Number of Participants for Each CYP2B6 Allele
timeFrame: Week 3
measure: Number of Slow and Fast Metabolizers by Genotype
timeFrame: Week 0
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Swope Health Central
state: Missouri
Study officials:
affiliation: University of Kansas
name: Lisa S. Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chenoweth MJ, Peng AR, Zhu AZX, Cox LS, Nollen NL, Ahluwalia JS, Benowitz NL, Knight J, Swardfager W, Tyndale RF. Does sex alter the relationship between CYP2B6 variation, hydroxybupropion concentration and bupropion-aided smoking cessation in African Americans? A moderated mediation analysis. Addiction. 2022 Jun;117(6):1715-1724. doi: 10.1111/add.15742. Epub 2021 Dec 3.
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
citation: El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1.
citation: Nollen NL, Mayo MS, Ahluwalia JS, Tyndale RF, Benowitz NL, Faseru B, Buchanan TS, Cox LS. Factors associated with discontinuation of bupropion and counseling among African American light smokers in a randomized clinical trial. Ann Behav Med. 2013 Dec;46(3):336-48. doi: 10.1007/s12160-013-9510-x.
citation: Clausius RL, Krebill R, Mayo MS, Bronars C, Martin L, Ahluwalia JS, Cox LS. Evaluation of the brief questionnaire of smoking urges in Black light smokers. Nicotine Tob Res. 2012 Sep;14(9):1110-4. doi: 10.1093/ntr/ntr267. Epub 2012 Jan 12.
citation: Berg CJ, Cox LS, Choi WS, Mayo MS, Krebill R, Bronars CA, Ahluwalia JS. Assessment of depression among African American light smokers. J Health Psychol. 2012 Mar;17(2):197-206. doi: 10.1177/1359105311414953. Epub 2011 Jul 20.
citation: Cox LS, Faseru B, Mayo MS, Krebill R, Snow TS, Bronars CA, Nollen NL, Choi WS, Okuyemi KS, Salzman GA, Benowitz NL, Tyndale RF, Ahluwalia JS. Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data. Trials. 2011 Jan 25;12:22. doi: 10.1186/1745-6215-12-22.