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Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikki Nollen, PhD, MA, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00781599
First received: October 27, 2008
Last updated: June 27, 2012
Last verified: June 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smokers
Interventions: Drug: Chantix
Behavioral: Adherence Counseling
Behavioral: Standard Counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized between March and August 2009. Participants were recruited from Swope Health Central.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chantix for 3 Months, Standard Counseling Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
Chantix for 3 Months and Adherence Counseling Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.

Participant Flow:   Overall Study
    Chantix for 3 Months, Standard Counseling   Chantix for 3 Months and Adherence Counseling
STARTED   36   36 
COMPLETED   29   32 
NOT COMPLETED   7   4 
Lost to Follow-up                7                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chantix for 3 Months, Standard Counseling Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
Chantix for 3 Months and Adherence Counseling Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
Total Total of all reporting groups

Baseline Measures
   Chantix for 3 Months, Standard Counseling   Chantix for 3 Months and Adherence Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   72 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   34   70 
>=65 years   0   2   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.3786  (11.046)   49.1980  (11.222)   46.788  (11.320) 
Gender 
[Units: Participants]
     
Female   21   12   33 
Male   15   24   39 
Region of Enrollment 
[Units: Participants]
     
United States   36   36   72 


  Outcome Measures
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1.  Primary:   Percent Compliance With Chantix   [ Time Frame: Months 1, 2, 3 ]

2.  Secondary:   Cotinine Verified 7 Day Point Prevalence Smoking Abstinence   [ Time Frame: Month 3 ]

3.  Secondary:   Carbon Monoxide-verified Abstinence   [ Time Frame: Month 1 ]

4.  Secondary:   Carbon Monoxide-verified Abstinence   [ Time Frame: Month 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nikki Nollen
Organization: University of Kansas Medical Center
phone: (913) 588-3784
e-mail: NNOLLEN@kumc.edu



Responsible Party: Nikki Nollen, PhD, MA, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00781599     History of Changes
Other Study ID Numbers: 11500
Study First Received: October 27, 2008
Results First Received: April 19, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board