This randomized clinical trial studies varenicline to see how well it works compared with placebo (inactive substance) in helping African American daily smokers quit smoking. Studies have shown that African Americans have higher rates of tobacco-related diseases, such as cancer, than the general population. African Americans also have a harder time quitting smoking. While the majority of African American daily smokers are light smokers, using 1-10 cigarettes per day, this is the first clinical trial to include African Americans of all smoking levels and to examine nicotine and carcinogen exposure in relation to smoking level and abstinence outcomes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02360631.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of varenicline versus placebo for tobacco use treatment among African American smokers.
SECONDARY OBJECTIVES:
I. To examine the effects of varenicline independently in light smokers and independently in moderate to heavy smokers.
II. To examine the relationship between baseline intake of nicotine and smoking level, and in relation to carcinogen exposure and abstinence in African American smokers.
III. To describe psychological, smoking, and treatment-related characteristics of African American smokers and evaluate these in association with abstinence.
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
GROUP I: Participants (n=300) receive varenicline orally (PO) twice daily (BID) for 12 weeks.
GROUP II: Participants (n=200) receive placebo PO BID for 12 weeks.
In both groups, participants undergo health education counseling in 30-minute sessions at weeks 0, 4, 8, 12, 16, and by telephone at week 1. Sessions include cognitive and behavioral components, and integrate the Kick It at Swope: Stop Smoking Guide, a health education guide distributed to participants.
After completion of study treatment, participants are followed up at Week 16 and then at Month 6.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorLisa Sanderson Cox
