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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Randomized Study of Health Education Counseling With Versus Without Bupropion Hydrochloride in African-Americans Who Are Light Smokers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Behavioral study, Biomarker/Laboratory analysis, Educational/Counseling/Training, Prevention Active 18 and over NCI KUMC-HSC-10332 10332, KUMC-070313, NCT00666978

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has smoked no more than 10 cigarettes a day for at least 2 years
• Has smoked for at least 25 days in the past month
• No use of other forms of tobacco in the past month
• Has a home address and telephone
• Not planning to move from the Kansas City metro area in the next year
• More than 1 month since nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed) to one of two groups.

Participants in group one will receive bupropion by mouth once or twice a day for 7 weeks. They will also receive health education counseling sessions during clinic visits in weeks 1, 4, and 8 and over the telephone in weeks 2, 6, and 17. During the health education counseling sessions, participants will receive a culturally-sensitive stop-smoking guide to discuss with their counselor and information about the risks of continued smoking and the benefits of stopping smoking. They will also develop a plan to stop smoking and learn about building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers, and use of medication to stop smoking.

Participants in group two will receive a placebo by mouth once or twice a day for 7 weeks. They will also receive health education counseling sessions during clinic visits in weeks 1, 4, and 8 and over the telephone in weeks 2, 6, and 17. During the health education counseling sessions, participants will receive a culturally-sensitive stop-smoking guide to discuss with their counselor and information about the risks of continued smoking and the benefits of stopping smoking. They will also develop a plan to stop smoking and learn about building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers, and use of medication to stop smoking.

Participants will fill out questionnaires in week 1.

Participants will undergo blood sample collection in weeks 1 and 4 for laboratory studies. Before blood sample collection in week 1, participants will smoke one cigarette. Some participants will also undergo saliva sample collection in weeks 8 and 27 for laboratory studies.

After finishing the study, patients will be evaluated at 6 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

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

Lisa Cox, PhD, Principal investigator		Ph: 913-588-2643 Email: lcox@kumc.edu

U.S.A.
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
Missouri
	Kansas City
	Swope Health Central
		Contact Person	Ph:  816-627-2122

Registry Information
Official Title		Enhancing Tobacco Use Treatment for African American Light Smokers
Trial Start Date		2007-12-17
Trial Completion Date		2009-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00666978
Date Submitted to PDQ		2008-01-04
Information Last Verified		2008-12-21
NCI Grant/Contract Number		CA091912