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

NCT00666978 | Completed Phase 4 Results

• 4 other identifiers: 10332R01CA091912KUMC-HSC-10332KUMC-070313
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Slow and Fast Metabolizers by Metabolite Ratio

  Weeks 0

• Number of Participants for Each CYP2B6 Allele

  Week 3

• Number of Slow and Fast Metabolizers by Genotype

  Week 0

Study Arms (2)

Bupropion Arm

EXPERIMENTAL

Subjects undergo smoking cessation intervention and take bupropion.

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

Health Education Arm

PLACEBO COMPARATOR

Subjects receive counseling intervention and take placebo.

Behavioral: smoking cessation intervention; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Other: counseling intervention; Other: educational intervention; Procedure: psychosocial assessment and care

Interventions

smoking cessation intervention BEHAVIORAL

Bupropion Arm; Health Education Arm

bupropion hydrochloride DRUG

Bupropion Arm

gene expression analysis GENETIC

Bupropion Arm; Health Education Arm

polymerase chain reaction GENETIC

Bupropion Arm; Health Education Arm

counseling intervention OTHER

Bupropion Arm; Health Education Arm

educational intervention OTHER

Bupropion Arm; Health Education Arm

psychosocial assessment and care PROCEDURE

Bupropion Arm; Health Education Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lisa Sanderson Cox, PhD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

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

Kansas City, Kansas, 66160-7357, United States

Location

Swope Health Central

Kansas City, Missouri, 64130, United States

Location

Related Publications (8)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Leukemia; Liver Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Tobacco Use Disorder; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Leukemia, Myeloid, Acute

Interventions

Bupropion; Gene Expression Profiling; Polymerase Chain Reaction; Counseling; Early Intervention, Educational; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Kidney Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Mouth Diseases; Nasopharyngeal Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Rehabilitation; Therapeutics

Limitations and Caveats

Over half of the participants who expressed interest in this study were ineligible according to study protocol. The lack of assessment between standardized assessment points limited the ability to characterize the process of relapse.

Results Point of Contact

• Title: Lisa Sanderson Cox
• Organization: University of Kansas Medical Center

lcox@kumc.edu

913-588-2643

Study Officials

• Lisa S. Cox, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 13, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-10

Locations

US (2)