Advancing Tobacco Use Treatment for African American Smokers (KIS-IV)

Lisa Sanderson Cox, PhD

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Placebo; Drug: Chantix

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02360631

STUDY00000721

R01DA035796 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

500 participants in 2 patient groups, including a placebo group

Chantix (varenicline)

Experimental group

Description:

Participants will receive 1mg pills to take twice a day for 12 weeks.

Treatment:

Drug: Chantix

Placebo

Placebo Comparator group

Description:

Participants will receive a placebo pill to take twice a day for 12 weeks.

Treatment:

Drug: Placebo