This clinical trial tests whether extending treatment with bupropion and smoking cessation counseling improves smoking abstinence outcomes in the African American community. Smoking is the leading cause of disease and death in the United States. African Americans have higher rates of tobacco-related disease than the general population. African Americans smoke fewer cigarettes per day than Whites but have a harder time quitting, without knowing why. Bupropion is a non-nicotine aid to help people quit smoking by reducing withdrawal symptoms. This trial examines whether or not giving bupropion, in conjunction with smoking cessation counseling, for a longer time will help more smokers quit smoking. Researchers also hope to identify factors that make quitting smoking harder for some African Americans and easier for others. Findings from this study could help researchers figure out ways to improve treatment and make quitting easier for African American smokers.
Additional locations may be listed on ClinicalTrials.gov for NCT05732272.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Contact: Lisa Sanderson Cox
Phone: 913-588-2643
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of extended bupropion treatment (6 months) versus standard bupropion treatment (7 weeks) to promote smoking cessation among African American smokers.
II. To examine adherence over the course of treatment and its impact on smoking abstinence.
III. To evaluate the impact of extended treatment versus standard bupropion treatment on change in negative affect, withdrawal, and craving.
IV. To identify the set of individual factors that best predict smoking abstinence.
V. To characterize patterns of tobacco use and smoking abstinence over the course of standard and extended treatment.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (STANDARD): Participants recieve bupropion orally (PO) once daily (QD) for 3 days and then twice daily (BID) for 7 weeks. Participants also complete 5, 20-minute smoking cessation counseling sessions over weeks 0-12 on trial.
ARM II (EXTENDED): Participants recieve bupropion PO QD for 3 days and then BID for 24 weeks. Participants also complete 8, 20-minute smoking cessation counseling sessions over week 0 to month 6 on trial.
Upon completion of study intervention, patients are followed up at at months 7, 9, and 12 after enrollment.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorLisa Sanderson Cox
