This trial is active, not recruiting.

Condition smoking cessation
Treatment varenicline
Phase phase 4
Sponsor Nikki Nollen, PhD, MA
Collaborator National Institute on Drug Abuse (NIDA)
Start date June 2012
End date April 2017
Trial size 449 participants
Trial identifier NCT01836276, 12990, 1R01DA031815-01A1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
varenicline Chantix®
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
(Active Comparator)
varenicline Chantix®
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines

Primary Outcomes

cotinine-verified 7-day point prevalence smoking abstinence
time frame: Change from Baseline to Week 26

Eligibility Criteria

Male or female participants at least 18 years old.

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 KC during the treatment and follow-up phase - Another household member enrolled in the study

Additional Information

Official title Understanding Disparities in Quitting in African American and White Smokers
Principal investigator Nikki Nollen, PhD, MA
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 SR. 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.