Understanding Disparities in Quitting in African American and White Smokers

Smoking Cessation Clinical Trial

Official title:

Understanding Disparities in Quitting in African American and White Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836276
• Other study ID #: 12990
• Secondary ID: 1R01DA031815-01A
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: April 2017

Study information

• Verified date: September 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Swope Health Central	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Nikki Nollen, PhD, MA	National Institute on Drug Abuse (NIDA), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26	Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.	Change from Baseline to Week 26