Status:
COMPLETED
Understanding Disparities in Quitting in African American and White Smokers
Lead Sponsor:
Nikki Nollen, PhD, MA
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT01836276
Start Date
February 1 2013
End Date
April 1 2017
Last Update
October 24 2018
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Swope Health Central
Kansas City, Missouri, United States, 64130