Understanding Disparities in Quitting in African American and White Smokers
NCT01836276
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Understanding Disparities in Quitting in African American and White Smokers | |||
Official Title ICMJE | Understanding Disparities in Quitting in African American and White Smokers | |||
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 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Smoking Cessation | |||
Intervention ICMJE | Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines Other Name: Chantix® | |||
Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 449 | |||
Original Estimated Enrollment ICMJE | 448 | |||
Actual Study Completion Date ICMJE | April 2017 | |||
Actual Primary Completion Date | April 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01836276 | |||
Other Study ID Numbers ICMJE | 12990 1R01DA031815-01A1 ( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Nikki Nollen, PhD, MA, University of Kansas Medical Center | |||
Study Sponsor ICMJE | Nikki Nollen, PhD, MA | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Kansas Medical Center | |||
Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |