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
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.

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  
Number of Participants  
[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 ]
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Measure Type Primary
Measure Title Percent Compliance With Chantix
Measure Description Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.
Time Frame Months 1, 2, 3  
Safety Issue No  

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.
Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.

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.

Measured Values
    Chantix for 3 Months, Standard Counseling     Chantix for 3 Months and Adherence Counseling  
Number of Participants Analyzed  
[units: participants]
  36     36  
Percent Compliance With Chantix  
[units: Percentage¬†of¬†Participants]
Mean ± Standard Deviation
   
Month 1     90.7  ± 9.5     85.8  ± 23.0  
Month 2     87.1  ± 18.9     91.7  ± 17.4  
Month 3     89.2  ± 24.4     82.1  ± 36.4  

No statistical analysis provided for Percent Compliance With Chantix



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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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


No publications provided


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