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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00835900
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Drug: varenicline
Drug: placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extended Run-In Standard Run-In
Hide Arm/Group Description The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.

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.

Period Title: Overall Study
Started 32 28
Completed 27 22
Not Completed 5 6
Arm/Group Title Extended Run-In Standard Run-In Total
Hide Arm/Group Description The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.

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 of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
48  (10) 49  (10) 48  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
18
  56.3%
17
  60.7%
35
  58.3%
Male
14
  43.8%
11
  39.3%
25
  41.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Nonwhite
3
   9.4%
5
  17.9%
8
  13.3%
White
29
  90.6%
23
  82.1%
52
  86.7%
Baseline CPD  
Mean (Standard Deviation)
Unit of measure:  Cigarettes Per Day
Number Analyzed 32 participants 28 participants 60 participants
21  (5) 21  (5) 21  (5)
1.Primary Outcome
Title Change in Smoking Behavior
Hide Description Change in cigarettes per day from Week 2 to Week 5
Time Frame Change in cigarettes per day from Week 2 to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Extended Run-In Standard Run-In
Hide Arm/Group Description:
The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.

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.

Overall Number of Participants Analyzed 32 28
Mean (Standard Error)
Unit of Measure: Change in Cigarettes Per Day
-6.3  (0.9) -3.2  (0.7)
2.Secondary Outcome
Title Rates of Smoking Cessation.
Hide Description To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.
Time Frame 12 weeks after quit date.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Extended Run-In Standard Run-In
Hide Arm/Group Description:
The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.

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.

Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
17
  53.1%
11
  39.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended Run-In Standard Run-In
Hide Arm/Group Description The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.

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.

All-Cause Mortality
Extended Run-In Standard Run-In
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Extended Run-In Standard Run-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      1/28 (3.57%)    
Psychiatric disorders     
Irritability  [1]  0/32 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
One participant in the Standard run-in arm who reported feelings of hostility and irritability 3 weeks after being started on varenicline
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended Run-In Standard Run-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/32 (56.25%)      6/28 (21.43%)    
Gastrointestinal disorders     
Nausea   18/32 (56.25%)  18 6/28 (21.43%)  6
Constipation   8/32 (25.00%)  8 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
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
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
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: March 13, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017