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Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
This study is currently recruiting participants.
Verified by University of Kansas, November 2008
Sponsored by: University of Kansas
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00781599
  Purpose

Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3


Condition Intervention
Smokers
Drug: Chantix
Other: Chantix and Induction Support Counseling

MedlinePlus related topics: Quitting Smoking Smoking
Drug Information available for: Varenicline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title: Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • compliance with Chantix [ Time Frame: month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cotinine verified 7 day point prevalence smoking abstinence [ Time Frame: previous 7 days at month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Chantix for 3 months
Drug: Chantix
Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3
2: Experimental
Chantix for 3 months and Induction Support Counseling
Other: Chantix and Induction Support Counseling
Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3, Induction Support counseling on days 8, 12, 20 and months 1 and 2

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • 18-75 years of age
  • Smoke more than 10 cigarettes per day
  • Have a functioning telephone number
  • Be interested in quitting smoking
  • Be willing to take 3 months of Chantix
  • Be willing to complete all study visits

Exclusion Criteria:

  • Renal impairment
  • Evidence or history of clinically significant allergic reactions to Chantix
  • Cardiovascular event in the past month
  • History of alcohol or drug abuse/dependency in the past year
  • Major depressive disorder in the last year requiring treatment
  • History of panic disorder
  • Psychosis, bipolar or eating disorder
  • Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone
  • Use of tobacco products other than cigarettes
  • Use of nicotine replacement therapy, buproprion, clonidine or nortriptyline in the month prior to enrollment
  • Prior use of Chantix
  • Women who are pregnant, contemplating getting pregnant or breastfeeding
  • Plans to move from Kansas City during the 3 month treatment phase
  • Another household member enrolled in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781599

Contacts
Contact: Nicole Nollen, PhD 913-588-3784 nnollen@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Nicole Nollen, PhD     913-588-3784     nnollen@kumc.edu    
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Nicole Nollen, PhD University of Kansas
  More Information

Responsible Party: University of Kansas Medical Center ( Nicole Nollen PhD )
Study ID Numbers: 11500
Study First Received: October 27, 2008
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00781599  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
African american
smokers
smoking cessation
African American smokers

Study placed in the following topic categories:
Smoking

ClinicalTrials.gov processed this record on January 16, 2009