Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Understanding Disparities in Quitting in African American and White Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836276
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : September 21, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Pfizer
Information provided by (Responsible Party):
Nikki Nollen, PhD, MA, University of Kansas Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Understanding Disparities in Quitting in African American and White Smokers
Actual Study Start Date : February 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: African American (AA) Smokers
AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
 Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Other Name: Chantix®
Active Comparator: White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
 Drug: Varenicline
1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Other Name: Chantix®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 [ Time Frame: Change from Baseline to 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836276


Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Swope Health Central
Kansas City, Missouri, United States, 64130
Sponsors and Collaborators
Nikki Nollen, PhD, MA
National Institute on Drug Abuse (NIDA)
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: Nikki Nollen, PhD, MA University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by Nikki Nollen, PhD, MA, University of Kansas Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 17, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Nikki Nollen, PhD, MA, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01836276    
Other Study ID Numbers: 12990
1R01DA031815-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2013    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: October 24, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs