NCT00666978 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2017-11-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months

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outcome · POSTED

Number of Slow and Fast Metabolizers by Metabolite Ratio

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outcome · POSTED

Number of Participants for Each CYP2B6 Allele

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outcome · POSTED

Number of Slow and Fast Metabolizers by Genotype

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects undergo smoking cessation intervention and take bupropion.
intervention Names
Behavioral: smoking cessation intervention
Drug: bupropion hydrochloride
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
label
Bupropion Arm
type
EXPERIMENTAL
description
Subjects receive counseling intervention and take placebo.
intervention Names
Behavioral: smoking cessation intervention
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
label
Health Education Arm
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Bupropion Arm
Health Education Arm
name
smoking cessation intervention
type
BEHAVIORAL
arm Group Labels
Bupropion Arm
name
bupropion hydrochloride
type
DRUG
arm Group Labels
Bupropion Arm
Health Education Arm
name
gene expression analysis
type
GENETIC
arm Group Labels
Bupropion Arm
Health Education Arm
name
polymerase chain reaction
type
GENETIC
arm Group Labels
Bupropion Arm
Health Education Arm
name
counseling intervention
type
OTHER
arm Group Labels
Bupropion Arm
Health Education Arm
name
educational intervention
type
OTHER
arm Group Labels
Bupropion Arm
Health Education Arm
name
psychosocial assessment and care
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 540
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
measure
Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
time Frame
6 months

secondary Outcomes

description
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.
measure
Number of Slow and Fast Metabolizers by Metabolite Ratio
time Frame
Weeks 0
description
We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
measure
Number of Participants for Each CYP2B6 Allele
time Frame
Week 3
description
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.
measure
Number of Slow and Fast Metabolizers by Genotype
time Frame
Week 0

Full study description

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.

Source references

references

citation
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
pmid
37230961
type
DERIVED
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.
pmid
34791718
type
DERIVED
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.
pmid
34611902
type
DERIVED
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.
pmid
33300144
type
DERIVED
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.
pmid
23733379
type
DERIVED
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.
pmid
22241828
type
DERIVED
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.
pmid
21775497
type
DERIVED
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.
pmid
21266057
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice