Completed

Understanding Disparities in Quitting in African American and White Smokers

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What is being tested

Varenicline

+ Varenicline

Drug
Who is being recruted

Behavior

+ Health Behavior

+ Smoking Cessation

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorNikki Nollen, PhD, MA
Last updated: October 24, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01836276
Principal SponsorNikki Nollen, PhD, MA
Last updated: October 24, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

449 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorHealth BehaviorSmoking Cessation

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Kansas Medical Center

Kansas City, United StatesOpen University of Kansas Medical Center in Google Maps

Swope Health Central

Kansas City, United States
Completed2 Study Centers