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Completed

NCT Number: NCT01836276

Understanding Disparities in Quitting in African American and White Smokers

The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines

Other names: Chantix®

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nikki Nollen, PhD, MA

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Pfizer

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2013
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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