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Efficacy of Varenicline in Ambivalent Smokers

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ClinicalTrials.gov Identifier: NCT00595868
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : November 22, 2011
Last Update Posted : December 2, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
John Hughes, University of Vermont Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tobacco Use Disorder
Tobacco Use Cessation
Nicotine Dependence
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 220
Recruitment Details  
Pre-assignment Details Enrolled sample size of 220; 2 were excluded because found to be ineligible after enrollment
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 2 milligrams varenicline once per day for 2-8 weeks Placebo once per day for 2-8 weeks
Period Title: Overall Study
Started 107 111
Completed 62 61
Not Completed 45 50
Reason Not Completed
Lost to Follow-up             45             50
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description 2 milligrams varenicline once per day for 2-8 weeks Placebo once per day for 2-8 weeks Total of all reporting groups
Overall Number of Baseline Participants 107 111 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 111 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
99
  92.5%
106
  95.5%
205
  94.0%
>=65 years
8
   7.5%
5
   4.5%
13
   6.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 111 participants 218 participants
44  (14) 41  (15) 42  (15)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 107 participants 111 participants 218 participants
Female 42 47 89
Male 64 63 127
Missing 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants 111 participants 218 participants
107 111 218
1.Primary Outcome
Title Number of Participants With a Quit Attempt
Hide Description A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
2 milligrams varenicline once per day for 2-8 weeks
Placebo once per day for 2-8 weeks
Overall Number of Participants Analyzed 107 111
Measure Type: Number
Unit of Measure: participants
55 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.0 to 2.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million
Hide Description 7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
2 milligrams varenicline once per day for 2-8 weeks
Placebo once per day for 2-8 weeks
Overall Number of Participants Analyzed 107 111
Measure Type: Number
Unit of Measure: participants
15 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
0.9 to 5.2
Estimation Comments [Not Specified]
Time Frame Adverse events (AEs) collected for 1 month after last dose of study medication, which varied from 2 weeks to 5 months
Adverse Event Reporting Description Since this is a marketed drug we did not enter data about expected non-serious AEs into our database. The 0 non-serious AEs does not imply that no AEs were >5%, only that we did not capture that for analysis.
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 2 milligrams varenicline once per day for 2-8 weeks Placebo once per day for 2-8 weeks
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/111 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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: John R. Hughes, MD
Organization: University of Vermont
Phone: 802-656-3195
Responsible Party: John Hughes, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT00595868     History of Changes
Other Study ID Numbers: IIR GA3051DO
IIR GA3051DO ( Other Grant/Funding Number: Pfizer )
First Submitted: January 4, 2008
First Posted: January 16, 2008
Results First Submitted: September 7, 2011
Results First Posted: November 22, 2011
Last Update Posted: December 2, 2011