Advancing Tobacco Use Treatment for African American Smokers

Smoking Cessation Clinical Trial

— KIS-IV  

Official title:

Advancing Tobacco Use Treatment for African American Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360631
• Other study ID #: STUDY00000721
• Secondary ID: R01DA035796
• Status: Completed
• Phase: Phase 4
• Start date: July 29, 2015
• Est. completion date: July 12, 2018

Study information

• Verified date: July 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Chantix
A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
• Placebo
Health education counseling will be provided to all participants.

Locations

Country	Name	City	State
United States	Swope Health Central	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Lisa Sanderson Cox, PhD	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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