Understanding Disparities in Quitting in African American and White Smokers

September 24, 2018 updated by: Nikki Nollen, PhD, MA
The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.

Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-Hispanic African American or non-Hispanic White
  • ≥ 18 years of age
  • Smoked 3-20 cigarettes per day
  • Smoked 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 Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:

    • Angina
    • Myocardial infarction
    • Peripheral vascular disease
    • Stroke
  • New onset of chest pain or arrhythmia in the past 2 months
  • History of alcohol or drug dependency 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: African American (AA) Smokers
AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Other Names:
  • Chantix®
Active Comparator: White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Other Names:
  • Chantix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
Time Frame: Change from Baseline to Week 26
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
Change from Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nikki Nollen, PhD, MA

Collaborators

National Institute on Drug Abuse (NIDA)
Pfizer

Investigators

  • Principal Investigator: Nikki Nollen, PhD, MA, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12990
  • 1R01DA031815-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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