Advancing Tobacco Use Treatment for African American Smokers

Phase 4

Completed

Conditions: Smoking Cessation

Interventions: Drug: Chantix
Drug: Placebo

Registration Number: NCT02360631

Lead Sponsor: Lisa Sanderson Cox, PhD

Brief Summary: The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

Detailed Description: To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking \>10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

Inclusion Criteria

Self-identified African American
Smokes ≥ 1 cigarette 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

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 during the treatment and follow-up phase
Another household member enrolled in the study
Evidence of current severe major depressive disorder or suicidal ideation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chantix (varenicline)	Chantix	Participants will receive 1mg pills to take twice a day for 12 weeks.
Placebo	Placebo	Participants will receive a placebo pill to take twice a day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Abstinence at Month 6	Month 6	Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Abstinence at Week 12	Week 12	Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit
Number of Participants With Smoking Abstinence at Week 26	Week 26	Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment

Trial Locations

Locations (2): Swope Health Central
🇺🇸
Kansas City, Missouri, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States