Understanding Disparities in Quitting in African American and White Smokers

Nikki Nollen, PhD, MA

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Varenicline

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01836276

1R01DA031815-01A1 (U.S. NIH Grant/Contract)

12990

Details and patient eligibility

About

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

Full 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.

Enrollment: 449 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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449 participants in 2 patient groups

African American (AA) Smokers

Experimental group

Description:

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

Treatment:

Drug: Varenicline

White Smokers

Active Comparator group

Description:

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

Treatment:

Drug: Varenicline