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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Chantix; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Swope Health Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chantix (varenicline); Participants will receive 1mg pills to take twice a day for 12 weeks.	Drug: Chantix; A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.; Other Names: Varenicline
Placebo Comparator: Placebo; Participants will receive a placebo pill to take twice a day for 12 weeks.	Drug: Placebo; Health education counseling will be provided to all participants.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lisa Sanderson Cox, PhD
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lisa Sanderson Cox, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Cox LS, Nollen NL, Mayo MS, Faseru B, Greiner A, Ellerbeck EF, Krebill R, Tyndale RF, Benowitz NL, Ahluwalia JS. Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial. JAMA. 2022 Jun 14;327(22):2201-2209. doi: 10.1001/jama.2022.8274.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2015
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: smoking; quit smoking; smoking treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: STUDY00000721; R01DA035796 (U.S. NIH Grant/Contract)