Understanding Disparities in Quitting in African American and White Smokers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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African American (AA) Smokers

AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

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

White Smokers

White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

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

Interventions

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Varenicline

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

Intervention Type DRUG

Other Intervention Names

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Chantix®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No