Understanding Disparities in Quitting in African American and White Smokers

NCT01836276

Last updated date
Study Location
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Understanding Disparities in Quitting in African American and White Smokers
Official Title  ICMJE Understanding Disparities in Quitting in African American and White Smokers
Brief Summary The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Other Name: Chantix®
Study Arms  ICMJE
  • Experimental: African American (AA) Smokers
    AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
    Intervention: Drug: Varenicline
  • Active Comparator: White Smokers
    White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
    Intervention: Drug: Varenicline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
449
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2013)
448
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01836276
Other Study ID Numbers  ICMJE 12990
1R01DA031815-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nikki Nollen, PhD, MA, University of Kansas Medical Center
Study Sponsor  ICMJE Nikki Nollen, PhD, MA
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Nikki Nollen, PhD, MAUniversity of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP