Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring Smoking Behaviors While Using Varenicline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00948155
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : December 16, 2014
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Andrew Strasser, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nicotine Dependence
Intervention Drug: Varenicline
Enrollment 48
Recruitment Details Recruitment occurred in a research laboratory in a school of medicine. Dates of recruitment: first participant first visit March 31, 2009; last participants last visit December 02, 2010
Pre-assignment Details

48 participants signed consents and were enrolled in the study. Medical clearance was achieved by 41; 29 returned for the first laboratory visit which is the first day drug/placebo was administered. The 12 who did not return for the Day 1 visit were not included further in the study.

There was a minimum 14 washout period between drug conditions.

Arm/Group Title Placebo Then Varenicline Varenicline Before Placebo
Hide Arm/Group Description

Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Period Title: First Intervention 21 Days
Started 14 15
Completed 12 13
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Period Title: Washout 14 Days
Started 12 13
Completed 11 11
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Period Title: Second Intervention 21 Days
Started 11 11
Completed 9 8
Not Completed 2 3
Arm/Group Title Placebo Then Varenicline Varenicline Before Placebo Total
Hide Arm/Group Description

Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
15
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
42.6  (13.7) 37.6  (12.8) 39.9  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
4
  28.6%
3
  20.0%
7
  24.1%
Male
10
  71.4%
12
  80.0%
22
  75.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Smoking Topography: Total Puff Volume
Hide Description Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.
Time Frame Days 1-21 of each of 2 study periods
Hide Outcome Measure Data
Hide Analysis Population Description
All those participants who completed both study periods were included in the analysis.
Arm/Group Title Placebo Then Varenicline Varenicline Before Placebo
Hide Arm/Group Description:

Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Overall Number of Participants Analyzed 9 8
Mean (Standard Error)
Unit of Measure: milliliters
523.4  (41) 684.6  (33)
2.Primary Outcome
Title The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
Hide Description Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.
Time Frame Days 1, 7, 21 of each of two 21 day study periods
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the task were included in the analysis
Arm/Group Title Placebo Then Varenicline Varenicline Before Placebo
Hide Arm/Group Description:

Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Overall Number of Participants Analyzed 9 8
Mean (Standard Error)
Unit of Measure: number of puffs chosen of a maximum 24
12  (4.5) 11.5  (5.1)
3.Primary Outcome
Title Daily Cigarette Consumption
Hide Description Average of the number of cigarettes smoked per day
Time Frame Two 21 day study periods
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: number of cigarettes smoked per day
Start of 21 day period 16.2  (1.4) 16.1  (0.86)
End of 21 day period 14.4  (1.2) 12.8  (1.3)
4.Secondary Outcome
Title Total Nicotine Metabolites From Urine Samples
Hide Description Total urinary metabolites from urine samples collected at Day 1 and Day 21
Time Frame Samples from Day 1 and Day 21 of two 21 day Periods
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both 21 day placebo and drug periods.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: micromolar
Day 1 110  (14) 111  (15)
Day 21 79  (14) 81  (9)
5.Secondary Outcome
Title Nicotine Levels From Urine Samples
Hide Description Nicotine levels from urine samples collected at Day 1 and Day 21.
Time Frame Samples from Day 1 and Day 21 of two 21 day Periods
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both 21 day placebo and drug periods.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: micromolar
Day 1 20.0  (6) 24.0  (5)
Day 21 18.0  (6) 13.8  (3)
6.Secondary Outcome
Title Cotinine Levels From Urine Samples
Hide Description Cotinine levels from urine samples collected at Day 1 and Day 21.
Time Frame Samples from Day 1 and Day 21 of two 21 day Periods
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both 21 day placebo and drug periods.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: micromolar
Day 1 19.0  (2) 16.9  (2)
Day 21 12.0  (2) 14.0  (2)
7.Secondary Outcome
Title Carbon Monoxide Levels
Hide Description Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.
Time Frame Samples from Day 1 and Day 21 of two 21 day Periods
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both 21 day placebo and drug periods.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: parts per million
Day 1 30  (4) 23.2  (2)
Day 21 25  (2) 22  (2)
8.Secondary Outcome
Title Subjective Measures to Assess Smoking Urges
Hide Description Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach’s α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.
Time Frame Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed both 21 day placebo and drug periods.
Arm/Group Title Placebo Varenicline
Hide Arm/Group Description:
21 days using placebo
21 days using Varenicline
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Factor 1 Day 1 4.2  (0.7) 4.3  (0.6)
Factor 1 Day 21 3.9  (0.6) 3.7  (0.4)
Factor 2 Day 1 2.5  (0.3) 2.8  (0.3)
Factor 2 Day 21 2.4  (0.4) 2.6  (0.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Systematic assessment of adverse events occurred at baseline, Days 1, 7, 21 when participant is present in research center.
 
Arm/Group Title Placebo Then Varenicline Varenicline Before Placebo
Hide Arm/Group Description

Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

All-Cause Mortality
Placebo Then Varenicline Varenicline Before Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Then Varenicline Varenicline Before Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Then Varenicline Varenicline Before Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Attrition rates were high. The final sample consisted primarily of Caucasian males, which may limit the generalizability of the present findings.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Andrew A. Strasser, Ph.D., Associate Professor
Organization: University of Pennsylvania
Phone: 215 746 5788
Responsible Party: Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948155     History of Changes
Other Study ID Numbers: 808930
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: January 14, 2013
Results First Posted: December 16, 2014
Last Update Posted: December 16, 2014