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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00835900
First received: February 3, 2009
Last updated: April 24, 2017
Last verified: April 2017
Results First Received: March 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: varenicline
Drug: placebo

  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
No text entered.

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
Extended Run-In The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
Standard Run-In

The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.

Both groups received brief cognitive-behavioral counseling.


Participant Flow:   Overall Study
    Extended Run-In   Standard Run-In
STARTED   32   28 
COMPLETED   27   22 
NOT COMPLETED   5   6 



  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.
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Reporting Groups
  Description
Extended Run-In The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
Standard Run-In

The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.

Both groups received brief cognitive-behavioral counseling.

Total Total of all reporting groups

Baseline Measures
   Extended Run-In   Standard Run-In   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   28   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (10)   49  (10)   48  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  56.3%      17  60.7%      35  58.3% 
Male      14  43.8%      11  39.3%      25  41.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Nonwhite   3   5   8 
White   29   23   52 
Baseline CPD 
[Units: Cigarettes Per Day]
Mean (Standard Deviation)
 21  (5)   21  (5)   21  (5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Smoking Behavior   [ Time Frame: Change in cigarettes per day from Week 2 to Week 5 ]

2.  Secondary:   Rates of Smoking Cessation.   [ Time Frame: 12 weeks after quit date. ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Martin Mahoney
Organization: Roswell Park Cancer Institute
phone: 7168452300
e-mail: martin.mahoney@roswellpark.org



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00835900     History of Changes
Obsolete Identifiers: NCT00957515
Other Study ID Numbers: I 136208
Pfizer IIR-GA30523
Study First Received: February 3, 2009
Results First Received: March 13, 2017
Last Updated: April 24, 2017