Understanding Disparities in Quitting in African American and White Smokers
Varenicline
+ Varenicline
Behavior
+ Health Behavior
+ Smoking Cessation
Treatment Study
Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.449 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
University of Kansas Medical Center
Kansas City, United StatesOpen University of Kansas Medical Center in Google MapsSwope Health Central
Kansas City, United States