Varenicline for Smoking Cessation in African American Smokers

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Self-identified African American
  • Smokes >= 1 cigarettes per day (cpd)
  • Smoke on >= 25 days of the past 30 days
  • Functioning telephone
  • Interested in quitting smoking
  • Interested in taking 3 months of varenicline
  • Willing to complete all study visits
  • Medication approval from their own physician

Exclusion Criteria

  • Renal impairment
  • Evidence or history of clinically significant allergic reactions to varenicline
  • A cardiovascular event in the past month
  • History of alcohol or drug dependence in the past year
  • Major depressive disorder in the last year requiring treatment
  • History of panic disorder, psychosis, bipolar disorder, or eating disorders
  • Use of tobacco products other than cigarettes in past 30 days
  • Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
  • Pregnant, contemplating getting pregnant, or breastfeeding
  • Plans to move from Kansas City (KC) during the treatment and follow-up phase
  • Another household member enrolled in the study

Locations & Contacts

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Lisa Sanderson Cox
Phone: 913-588-2643
Email: LCox@kumc.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Prevention

Lead Organization

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Lisa Sanderson Cox

Trial IDs

Primary ID STUDY00000721
Secondary IDs NCI-2015-01529
Clinicaltrials.gov ID NCT02360631